Drug 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,
D-0690-2021
Product summary
- Event
- Event 88145
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22,824 tubes
- Official record key
drug-enforcement:D-0690-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: 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.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications