Drug product
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
D-1046-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 80629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,605 tubes
- Official record key
drug-enforcement:D-1046-2018
Official wording
Reason: Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Code information: Lot #: 356309, Exp. 3/2019
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Out of Specification