FDA-Drug2018-08-15Class II

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

Akorn, Inc.
Hazard

Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.

Sold states
Nationwide within the USA
Affected count
22,605 tubes
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2018

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