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.
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
Lot numbers, UPCs & expiration codes
Lot #: 356309, Exp. 3/2019
Where it was sold
Nationwide within the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1046-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 1, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 22,605 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1046-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80629
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 356309, Exp. 3/2019
- Postal code
- 60045-4862
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1046-2018
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 22,605 tubes
- Termination date
- Nov 6, 2020
- Reason for recall
- Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Aug 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2018