Lidocaine 2.5% and Prilocaine Cream recall: Impurity Out of Spec
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
Why was Lidocaine 2.5% and Prilocaine Cream recalled?
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 356309, Exp. 3/2019
- 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
- Recalling firm
- Akorn, Inc.
- Quantity
- 22,605 tubes
- Distribution
- Nationwide within the USA
- Recall date
- August 15, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)