Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1077-2014·Announced 2014-02-12

FAMILY wellness Triple Antibiotic Ointment Recalled for Microbial Contamination

Faria Limited LLC is recalling FAMILY wellness Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Faria Limited LLC dba Sheffield Pharmaceuticals is recalling specific lots of FAMILY wellness Triple Antibiotic Ointment, 1 OZ (28 g). The product is an over-the-counter medication distributed by Family Dollar Services, Inc. The recall affects 147,566 units distributed nationwide.

The recall was initiated because elevated counts of gram-positive rods were found during environmental testing. This indicates microbial contamination of the non-sterile product. The affected lots have expiration dates of 12/13 and specific lot codes including 20022, 20031, 20032, 20041, 20042, 20051, 20052, 20061, 20071, and 20072.

Consumers who have purchased this product should check their lot numbers and expiration dates against the list provided. If the product matches the recalled lots, consumers should stop using it and return it to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product: FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
Manufacturer: Faria Limited LLC dba Sheffield Pharmaceuticals
Category: Drug — Topical Antibiotic
Hazard: microbial-contamination
Affected units: 147,566

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

20022 EXP. 12/13
20031 EXP. 12/13
20032 EXP. 12/13
20041 EXP. 12/13
20042 EXP. 12/13
20051 EXP. 12/13
20052 EXP. 12/13
20061 EXP. 12/13
20071 EXP. 12/13
20072 EXP. 12/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Faria Limited LLC dba Sheffield Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Faria Limited LLC dba Sheffield Pharmaceuticals

See all →

Moderate
Sheffield Triple Antibiotic Ointment Recalled for Microbial Contamination
FDA (Drugs) · 2014-02-12
High
Sheffield Pharmaceuticals Recalls Dollar General Triple Antibiotic Ointment for Microbial Contamination
FDA (Drugs) · 2014-02-12
Low
Sheffield Triple Antibiotic Ointment Recalled for Stability Failures
FDA (Drugs) · 2013-06-26

Same hazard · microbial contamination