Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- August 1, 2018
- Posted
- August 15, 2018
- Recall Number
- D-1046-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 22,605 tubes
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Distribution
Nationwide within the USA
Lot / Code Info
Lot #: 356309, Exp. 3/2019
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