Recalls / Class II
Class IID-1046-2018
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
- Affected lot / code info
- Lot #: 356309, Exp. 3/2019
Why it was recalled
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 22,605 tubes
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2018-08-01
- FDA classified
- 2018-08-07
- Posted by FDA
- 2018-08-15
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1046-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.