Drug 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.
D-0716-2022
Product summary
- Event
- Event 89560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11040 tubes
- Official record key
drug-enforcement:D-0716-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Code information: Lot: 15724, Exp. 06/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications