Drug recall: ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
Class II FDA enforcement event 62416. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Franck's Lab Inc., d.b.a. Franck's Compounding Lab started this drug recall on 25 May 2012. The firm address in the FDA record is in Ocala, FL. FDA put the recall in Class II. FDA event 62416 has 100 product records. The first FDA enforcement report date is 22 Aug 2012. The record gives the status Terminated, with the termination date 13 Aug 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
100 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1447-2012 | ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS) | 10 units | Class II | Terminated | 22 Aug 2012 |
| D-1448-2012 | ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1449-2012 | ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS) | 16 units | Class II | Terminated | 22 Aug 2012 |
| D-1450-2012 | ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS) | 3 units | Class II | Terminated | 22 Aug 2012 |
| D-1451-2012 | AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS) | 4 units | Class II | Terminated | 22 Aug 2012 |
| D-1452-2012 | ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML;… | 529 units | Class II | Terminated | 22 Aug 2012 |
| D-1453-2012 | ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2")… | 16 units | Class II | Terminated | 22 Aug 2012 |
| D-1454-2012 | AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG VIAL INJECTABLE 1 KIT,1 VIAL, 2 KIT, 2 KITS, 2 VIAL, 4 KIT, 4 VIAL; AMIKACIN SULFATE, LYOPHILIZED, OPHTHALMIC KIT 4MG VIAL INJECTABLE 1 KIT, 2 KIT, 4 KITS, 6 KIT; AMIKACIN SULFATE,… | 42 units | Class II | Terminated | 22 Aug 2012 |
| D-1455-2012 | AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1456-2012 | AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML NASO-NEB 60 ML (10 DIFFERENT PRODUCTS) | 15 units | Class II | Terminated | 22 Aug 2012 |
| D-1457-2012 | ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML; ASCORBIC/B1/B2/B3/B5/B6/B12/METHIONINE/INOSITOL/CHOLINE/LIDO INJECTABLE 40 ML, 50… | 19 units | Class II | Terminated | 22 Aug 2012 |
| D-1458-2012 | ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS) | 32 units | Class II | Terminated | 22 Aug 2012 |
| D-1459-2012 | BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; BACLOFEN, PRESERVATIVE FREE 3000MCG/ML… | 21 units | Class II | Terminated | 22 Aug 2012 |
| D-1460-2012 | BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS) | 10 units | Class II | Terminated | 22 Aug 2012 |
| D-1461-2012 | BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS) | 6 units | Class II | Terminated | 22 Aug 2012 |
| D-1462-2012 | BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS) | 3 units | Class II | Terminated | 22 Aug 2012 |
| D-1463-2012 | BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS) | 27 units | Class II | Terminated | 22 Aug 2012 |
| D-1464-2012 | BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G,… | 2350 units | Class II | Terminated | 22 Aug 2012 |
| D-1465-2012 | BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS) | 7 units | Class II | Terminated | 22 Aug 2012 |
| D-1466-2012 | BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BIMIX 26MG/1MG/ML INJECTABLE 10 ML; BIMIX… | 448 units | Class II | Terminated | 22 Aug 2012 |
| D-1467-2012 | BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1468-2012 | BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML;… | 107 units | Class II | Terminated | 22 Aug 2012 |
| D-1469-2012 | BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1470-2012 | BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML,… | 79 units | Class II | Terminated | 22 Aug 2012 |
| D-1471-2012 | BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS) | 5 units | Class II | Terminated | 22 Aug 2012 |
| D-1472-2012 | BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1473-2012 | BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1474-2012 | BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1475-2012 | BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/50MG/ML INTRATHECAL 18… | 15 units | Class II | Terminated | 22 Aug 2012 |
| D-1476-2012 | BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1477-2012 | BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS) | 7 units | Class II | Terminated | 22 Aug 2012 |
| D-1478-2012 | BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS) | 16 units | Class II | Terminated | 22 Aug 2012 |
| D-1479-2012 | BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1480-2012 | CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GLUCONATE OPHTHALMIC IN ARTIFICIAL TEARS 1% OPHTHALMIC 500 ML (9 DIFFERENT PRODUCTS) | 21 units | Class II | Terminated | 22 Aug 2012 |
| D-1481-2012 | CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS) | 2 units | Class II | Terminated | 22 Aug 2012 |
| D-1482-2012 | CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 12 KIT 16 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 8 KIT CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE 0.2 ML 0.4 ML 0.6 ML… | 197 units | Class II | Terminated | 22 Aug 2012 |
| D-1483-2012 | CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED… | 193 units | Class II | Terminated | 22 Aug 2012 |
| D-1484-2012 | CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT) | 4 units | Class II | Terminated | 22 Aug 2012 |
| D-1485-2012 | CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS) | 3 units | Class II | Terminated | 22 Aug 2012 |
| D-1486-2012 | CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS) | 5 units | Class II | Terminated | 22 Aug 2012 |
| D-1487-2012 | COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS) | 3 units | Class II | Terminated | 22 Aug 2012 |
| D-1488-2012 | CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML VIAL) 1000MCG/ML INJECTABLE 10 ML, 20… | 86 units | Class II | Terminated | 22 Aug 2012 |
| D-1489-2012 | CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS) | 6 units | Class II | Terminated | 22 Aug 2012 |
| D-1490-2012 | CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT) | 3 units | Class II | Terminated | 22 Aug 2012 |
| D-1491-2012 | CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1492-2012 | CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1493-2012 | CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1494-2012 | CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML, 60 ML; CYCLOSPORINE (A)… | 40 units | Class II | Terminated | 22 Aug 2012 |
| D-1495-2012 | DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS) | 25 units | Class II | Terminated | 22 Aug 2012 |
| D-1496-2012 | DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT) | 9 units | Class II | Terminated | 22 Aug 2012 |
| D-1497-2012 | DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" )… | 73 units | Class II | Terminated | 22 Aug 2012 |
| D-1498-2012 | DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM… | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1499-2012 | DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS) | 5 units | Class II | Terminated | 22 Aug 2012 |
| D-1500-2012 | DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT) | 1 unit | Class II | Terminated | 22 Aug 2012 |
| D-1501-2012 | DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS) | 13 units | Class II | Terminated | 22 Aug 2012 |
| D-1502-2012 | DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS) | 5 units | Class II | Terminated | 22 Aug 2012 |
| D-1503-2012 | DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS) | 26 units | Class II | Terminated | 22 Aug 2012 |
| D-1504-2012 | DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS) | 6 units | Class II | Terminated | 22 Aug 2012 |
| D-1505-2012 | DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 1000 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO FORTIFIED IRRIGATION 50%/44%/1% SOLUTION 50… | 107 units | Class II | Terminated | 22 Aug 2012 |
| D-1506-2012 | DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS) | 8 units | Class II | Terminated | 22 Aug 2012 |
The table shows 60 of 100 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2012
- 209
- Share of these events in Class II
- 56%
- Product records in this event
- 100Median of the firm: 100
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 May 2012 | INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT) | Drug | Class II | 98 |
Official channels
- FDA enforcement report D-1447-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 62416. https://recallregister.com/fda/ii/62416/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- What quantity of product is in FDA event 62416?
- The event has 100 product records. The first record gives this quantity:
10 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2012 have the same class?
- 56% of the 209 drug events that started in 2012 are in Class II.