Drug recall: Lidocaine 4% Urethral Gel
Class II FDA enforcement event 66856. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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
Natures Pharmacy & Compounding Center started this drug recall on 1 Nov 2013. The firm address in the FDA record is in Asheville, NC. FDA put the recall in Class II. FDA event 66856 has 48 product records. The first FDA enforcement report date is 12 Mar 2014. The record gives the status Terminated, with the termination date 24 Apr 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.
NC
Recalling firm
Natures Pharmacy & Compounding Center, Asheville, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
48 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1098-2014 | Lidocaine 4% Urethral Gel | 104 syringes | Class II | Terminated | 12 Mar 2014 |
| D-1099-2014 | Acetylcysteine 10% ophthalmic | Class II | Terminated | 12 Mar 2014 | |
| D-1100-2014 | AMP/M-B12/Pyridox/Methionine Inositol | Class II | Terminated | 12 Mar 2014 | |
| D-1101-2014 | Bladder Instillation | Class II | Terminated | 12 Mar 2014 | |
| D-1102-2014 | Bleomycin Sulfate 1unit/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1103-2014 | Cyanocobalamin 100mcg/ml injection | Class II | Terminated | 12 Mar 2014 | |
| D-1104-2014 | Cyano B-12 p-f 1000mcg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1105-2014 | Cyano B-12 (Cmpd) 1000mcg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1106-2014 | Dexamethasone (pf) 0.05 % opth. | Class II | Terminated | 12 Mar 2014 | |
| D-1107-2014 | Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic | Class II | Terminated | 12 Mar 2014 | |
| D-1108-2014 | Dexamethasone phosphate 24mg/ml inj. | Class II | Terminated | 12 Mar 2014 | |
| D-1109-2014 | Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg | Class II | Terminated | 12 Mar 2014 | |
| D-1110-2014 | Ethanol 20% ophthal. | Class II | Terminated | 12 Mar 2014 | |
| D-1111-2014 | EDTA 3% ophthalmic | Class II | Terminated | 12 Mar 2014 | |
| D-1112-2014 | 5-Fluorouracil pf in methocel 1% opthal | Class II | Terminated | 12 Mar 2014 | |
| D-1113-2014 | 5-Fluorouracil 1% ophthal | Class II | Terminated | 12 Mar 2014 | |
| D-1114-2014 | Folic acid (pf) 10mg/cc inj | Class II | Terminated | 12 Mar 2014 | |
| D-1115-2014 | Gentamycin 80mg/1000cc 0.9% NS | Class II | Terminated | 12 Mar 2014 | |
| D-1116-2014 | L-Glutathione inhalation | Class II | Terminated | 12 Mar 2014 | |
| D-1117-2014 | Glutathione 6%/ascorbic 1%/DMSO 6.25% | Class II | Terminated | 12 Mar 2014 | |
| D-1118-2014 | Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% | Class II | Terminated | 12 Mar 2014 | |
| D-1119-2014 | Glutathione Inhalation 200mg/5ml | Class II | Terminated | 12 Mar 2014 | |
| D-1120-2014 | Hydroxocobalamin inj. | Class II | Terminated | 12 Mar 2014 | |
| D-1121-2014 | Hydroxyprogesterone Caproate | Class II | Terminated | 12 Mar 2014 | |
| D-1122-2014 | Idoxuridine 0.1% Ophthalmic | Class II | Terminated | 12 Mar 2014 | |
| D-1123-2014 | Methotrexate Intraocular 400mcg 0.1cc | Class II | Terminated | 12 Mar 2014 | |
| D-1124-2014 | Methylcobalamin | Class II | Terminated | 12 Mar 2014 | |
| D-1125-2014 | Novarel (IM) | Class II | Terminated | 12 Mar 2014 | |
| D-1126-2014 | Papaverine 1nj 30mg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1127-2014 | Papaverine 12mg/phent 1mg/Pros 9mcq/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1128-2014 | Prostaglandin all combinations | Class II | Terminated | 12 Mar 2014 | |
| D-1129-2014 | Pyridoxine (p-f) 100mg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1130-2014 | Renacidin Irrigation | Class II | Terminated | 12 Mar 2014 | |
| D-1131-2014 | Sodium Bicarbonate 8.4% inj. | Class II | Terminated | 12 Mar 2014 | |
| D-1132-2014 | Scopolamine 0.25 opth. | Class II | Terminated | 12 Mar 2014 | |
| D-1133-2014 | Tetracaine 0.5% ophth. | Class II | Terminated | 12 Mar 2014 | |
| D-1134-2014 | Tacrolimus (H20-based) 0.03% ophth. | Class II | Terminated | 12 Mar 2014 | |
| D-1135-2014 | Tacrolimus 0.02% opth. (H20-based) | Class II | Terminated | 12 Mar 2014 | |
| D-1136-2014 | Terbutaline/Ipratropium 0.5mg/2.5ml | Class II | Terminated | 12 Mar 2014 | |
| D-1137-2014 | Testosterone Cypionate 100mg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1138-2014 | Testosterone Cypionate 200mg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1139-2014 | Triamcinolone Acetonide 3mg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1140-2014 | Vancomycin (fortified) 25mg/ml opth | Class II | Terminated | 12 Mar 2014 | |
| D-1141-2014 | Vit A (olive oil) 0.1% opth. | Class II | Terminated | 12 Mar 2014 | |
| D-1142-2014 | Vitamin D (Ergocalciferol) 800 u/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1143-2014 | Voriconazole 1% opthal | Class II | Terminated | 12 Mar 2014 | |
| D-1144-2014 | Voriconazole 0.5mg/ml | Class II | Terminated | 12 Mar 2014 | |
| D-1145-2014 | Voriconazole 0.5mg/ml | Class II | Terminated | 12 Mar 2014 |
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 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 48
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-1098-2014The 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 66856. https://recallregister.com/fda/ii/66856/. 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:
NC
- What quantity of product is in FDA event 66856?
- The event has 48 product records. The first record gives this quantity:
104 syringes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.