Sheffield Pharmaceuticals Recalls Dollar General Triple Antibiotic Ointment for Microbial Contamination
Faria Limited LLC is recalling Dollar General 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination (gram-positive rods) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Faria Limited LLC dba Sheffield Pharmaceuticals is recalling 26,424 units of Dollar General Triple Antibiotic Ointment, 1 oz (28 g), OTC. The product is distributed by Dolgencorp LLC in Goodlettsville, TN, and was distributed nationwide.
The recall was initiated because elevated counts of gram-positive rods were found during environmental testing, indicating microbial contamination of the non-sterile product. The affected product has the code 20221 and an expiration date of 04/14.
Consumers who have this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072
- Manufacturer
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Category
- Drug — Topical Antibiotic
- Hazard
- Affected units
- 26,424
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 (1)
- 20221 EXP. 04/14
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 →Related recalls
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