Drug recall: Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55)…
Class II FDA enforcement event 66962. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
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
Faria Limited LLC dba Sheffield Pharmaceuticals started this drug recall on 22 Nov 2013. The firm address in the FDA record is in New London, CT. FDA put the recall in Class II. FDA event 66962 has 3 product records. The first FDA enforcement report date is 12 Feb 2014. The record gives the status Terminated, with the termination date 9 Jun 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
Recalling firm
Faria Limited LLC dba Sheffield Pharmaceuticals, New London, CT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1076-2014 | Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320 | 332508 | Class II | Terminated | 12 Feb 2014 |
| D-1077-2014 | FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105 | 147566 | Class II | Terminated | 12 Feb 2014 |
| D-1078-2014 | Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072 | 26424 | Class II | Terminated | 12 Feb 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
- 3Median of the firm: 3
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 May 2013 | Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units Event 65349 | Drug | Class III | 1 |
Official channels
- FDA enforcement report D-1076-2014The 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.
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Cite this page
Recall Register. FDA enforcement event 66962. https://recallregister.com/fda/ii/66962/. 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
- What quantity of product is in FDA event 66962?
- The event has 3 product records. The first record gives this quantity:
332508
- 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.