Recalls / Class II
Class IID-0716-2022
Product
Erythromycin Topical Gel USP, 2%, Net Wt 30 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 63739-053-66.
- Affected lot / code info
- Lot: 15724, Exp. 06/2022
Why it was recalled
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 11040 tubes
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-02-07
- FDA classified
- 2022-03-24
- Posted by FDA
- 2022-02-23
- Terminated
- 2024-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0716-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.