The Recall Desk
ModerateFDA (Drugs)·D-0851-2022·Announced 2022-05-11

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.

What this means for you

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
  • cgmp-deviation

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

Distributed nationwide across the United States.

Related recalls

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