Drug recall: Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Class II FDA enforcement event 78553. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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
KRS Global Biotechnology, Inc started this drug recall on 16 Nov 2017. The firm address in the FDA record is in Boca Raton, FL. FDA put the recall in Class II. FDA event 78553 has 47 product records. The first FDA enforcement report date is 17 Jan 2018. The record gives the status Terminated, with the termination date 11 May 2020.
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 in the USA, Bermuda, and New Zealand
Recalling firm
KRS Global Biotechnology, Inc, Boca Raton, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
47 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0161-2018 | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 15,700 capsules | Class II | Terminated | 17 Jan 2018 |
| D-0162-2018 | Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 80 vials | Class II | Terminated | 17 Jan 2018 |
| D-0163-2018 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 22,520 capsules | Class II | Terminated | 17 Jan 2018 |
| D-0164-2018 | Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | 490 jars | Class II | Terminated | 17 Jan 2018 |
| D-0165-2018 | Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 4,530 jars | Class II | Terminated | 17 Jan 2018 |
| D-0166-2018 | Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 1,380 jars | Class II | Terminated | 17 Jan 2018 |
| D-0167-2018 | Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 3,280 jars | Class II | Terminated | 17 Jan 2018 |
| D-0168-2018 | Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | 300 jars | Class II | Terminated | 17 Jan 2018 |
| D-0169-2018 | Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 90 capsules | Class II | Terminated | 17 Jan 2018 |
| D-0170-2018 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 20 jars | Class II | Terminated | 17 Jan 2018 |
| D-0171-2018 | Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 100 jars | Class II | Terminated | 17 Jan 2018 |
| D-0172-2018 | Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 300 jars | Class II | Terminated | 17 Jan 2018 |
| D-0173-2018 | Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 2,239 tablets | Class II | Terminated | 17 Jan 2018 |
| D-0174-2018 | Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 1,203 vials | Class II | Terminated | 17 Jan 2018 |
| D-0175-2018 | Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 6,414 vials | Class II | Terminated | 17 Jan 2018 |
| D-0176-2018 | Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 2,239 vials | Class II | Terminated | 17 Jan 2018 |
| D-0177-2018 | Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 7,862 vials | Class II | Terminated | 17 Jan 2018 |
| D-0178-2018 | Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 2,274 vials | Class II | Terminated | 17 Jan 2018 |
| D-0179-2018 | Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 30 jars | Class II | Terminated | 17 Jan 2018 |
| D-0180-2018 | Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 1,009 vials | Class II | Terminated | 17 Jan 2018 |
| D-0181-2018 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 596 vials | Class II | Terminated | 17 Jan 2018 |
| D-0182-2018 | Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 40 jars | Class II | Terminated | 17 Jan 2018 |
| D-0183-2018 | Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | 970 capsules | Class II | Terminated | 17 Jan 2018 |
| D-0184-2018 | Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 696 vials | Class II | Terminated | 17 Jan 2018 |
| D-0185-2018 | Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 2,535 vials | Class II | Terminated | 17 Jan 2018 |
| D-0186-2018 | Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 963 bags | Class II | Terminated | 17 Jan 2018 |
| D-0187-2018 | PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 3,000 tablets | Class II | Terminated | 17 Jan 2018 |
| D-0188-2018 | Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 300 jars | Class II | Terminated | 17 Jan 2018 |
| D-0189-2018 | QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 126 vials | Class II | Terminated | 17 Jan 2018 |
| D-0190-2018 | QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 122 vials | Class II | Terminated | 17 Jan 2018 |
| D-0191-2018 | QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 129 vials | Class II | Terminated | 17 Jan 2018 |
| D-0192-2018 | Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 30 droptainers | Class II | Terminated | 17 Jan 2018 |
| D-0193-2018 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 3,000 tablets | Class II | Terminated | 17 Jan 2018 |
| D-0194-2018 | Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 80 cartridges | Class II | Terminated | 17 Jan 2018 |
| D-0195-2018 | Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 597 vials | Class II | Terminated | 17 Jan 2018 |
| D-0196-2018 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 157 vials | Class II | Terminated | 17 Jan 2018 |
| D-0197-2018 | Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 898 vials | Class II | Terminated | 17 Jan 2018 |
| D-0198-2018 | Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 235 vials | Class II | Terminated | 17 Jan 2018 |
| D-0199-2018 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 94 vials | Class II | Terminated | 17 Jan 2018 |
| D-0200-2018 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 173 vials | Class II | Terminated | 17 Jan 2018 |
| D-0201-2018 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 297 droptainers | Class II | Terminated | 17 Jan 2018 |
| D-0202-2018 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 81 droptainers | Class II | Terminated | 17 Jan 2018 |
| D-0203-2018 | Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 479 vials | Class II | Terminated | 17 Jan 2018 |
| D-0204-2018 | Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 3612 vials | Class II | Terminated | 17 Jan 2018 |
| D-0205-2018 | Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 5786 vials | Class II | Terminated | 17 Jan 2018 |
| D-0206-2018 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 90 capsules | Class II | Terminated | 17 Jan 2018 |
| D-0207-2018 | 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | 90 capsules | Class II | Terminated | 17 Jan 2018 |
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 2017
- 343
- Share of these events in Class II
- 57%
- Product records in this event
- 47Median of the firm: 47
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Sep 2019 | Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 | Drug | Class II | 80 |
| 16 Jan 2019 | NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnolog | Drug | Class II | 2 |
Official channels
- FDA enforcement report D-0161-2018The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 78553. https://recallregister.com/fda/ii/78553/. 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 in the USA, Bermuda, and New Zealand
- What quantity of product is in FDA event 78553?
- The event has 47 product records. The first record gives this quantity:
15,700 capsules
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2017 have the same class?
- 57% of the 343 drug events that started in 2017 are in Class II.