Recalls / Class III
Class IIID-0690-2021
Product
Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
- Affected lot / code info
- 1) NDC 52565-033-30 Lot 14010, Exp July 2021; 2) NDC 52565-033-60 Lot 13865, Exp June 2021; Lot 14011, Exp July 2021.
Why it was recalled
Failed Impurities/Degradation Specifications
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
- 22,824 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-06-22
- FDA classified
- 2021-07-19
- Posted by FDA
- 2021-07-28
- Terminated
- 2024-07-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0690-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.