Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Product description
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Lot numbers, UPCs & expiration codes
Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
Where it was sold
Nationwide within the United States
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-1518-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 17, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 33,939 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1518-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 83350
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
- Postal code
- 21202-6174
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1518-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 33,939 tubes
- Termination date
- Sep 14, 2020
- Reason for recall
- Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2019