Erythromycin Topical Gel Recalled Due to Manufacturing Quality Deviations
McKesson Corporation is recalling Erythromycin Topical Gel USP 2% due to CGMP deviations. The manufacturer discontinued its stability study program, prompting a nationwide recall of all products within their expiration date.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical, based on manufacturing quality deviations related to discontinuation of stability studies rather than any demonstrated product defect.
Plain-English summary
McKesson Corporation is recalling Erythromycin Topical Gel USP, 2%, in 60-gram tubes (NDC 63739-053-68). The recall includes 5,640 tubes of Lot 15723, which expire on 06/30/2022. Products have been distributed nationwide in the United States, including Guam and the Northern Mariana Islands.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm, Teligent Pharma, Inc., is discontinuing its stability study program. All products within their expiration date are included in this recall.
The recalled product
- Product
- Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68
- Manufacturer
- McKesson Corporation dba McKesson Drug Company
- Category
- Drug — Topical Antibiotic
- Hazard
- Affected units
- 5,640
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 (2)
- Lot: 15723
- Exp.: 06/30/2022
Distribution
Part of a larger recall action
This product is one of 5 recalled by McKesson Corporation dba McKesson Drug Company 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.
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