Why it was recalled
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Product description
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
Lot numbers, UPCs & expiration codes
Lot #: 1009431, 1009507, Exp. 08/2020; 1009886, 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-0514-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 7, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 58,176 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ACP Nimble Buyer, Inc.
Original FDA data
Every field from FDA enforcement report D-0514-2019, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80878
- Address
- 111 Coolidge St
- Code information
- Lot #: 1009431, 1009507, Exp. 08/2020; 1009886, Exp. 09/2020
- Postal code
- 07080-3801
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0514-2019
- Classification
- Class III
- Recalling firm
- ACP Nimble Buyer, Inc.
- Product quantity
- 58,176 units
- Termination date
- Mar 23, 2020
- Reason for recall
- Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2019