Clindamycin Phosphate — Class III drug recall D-0364-2024
Ongoing recall by Contract Pharmaceuticals Limited Canada, reported 2024-03-13, distributed nationwide. Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint
| Recall number | D-0364-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Contract Pharmaceuticals Limited Canada, Mississauga, Canada |
| Recall initiated | 2024-02-20 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 45,875 bottles |
| Reason classes | specification failure, packaging |
| NDC | 10135-0691-61 |
| Lot numbers | 119466, 119467, 120351, 121712 |
| Expiration dates | 2025-04, 2025-08, 2025-11 |
Product
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
Reason for recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0364-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.