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
Reported: August 15, 2018 Initiated: August 1, 2018 #D-1046-2018
Product Description
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
Reason for Recall
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 22,605 tubes
- Distribution
- Nationwide within the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 22,605 tubes.
Why was this product recalled? ▼
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1046-2018.
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