Why it was recalled
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Product description
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Lot numbers, UPCs & expiration codes
Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
Where it was sold
Nationwide in the U.S. and Puerto Rico
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-0364-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 20, 2024
- FDA report date
- Mar 13, 2024
- Quantity
- 45,875 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Contract Pharmaceuticals Limited Canada
Original FDA data
Every field from FDA enforcement report D-0364-2024, exactly as published.
Show all FDA fields
- City
- Mississauga
- Status
- Ongoing
- Country
- Canada
- Event ID
- 94066
- Address
- 7600 East Danbro Cres
- Code information
- Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
- Report date
- Mar 13, 2024
- Product type
- Drugs
- Recall number
- D-0364-2024
- Classification
- Class III
- Recalling firm
- Contract Pharmaceuticals Limited Canada
- Product quantity
- 45,875 bottles
- Reason for recall
- Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico
- Recall initiation date
- Feb 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2024