FDA Drug recall D-0364-2024
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Cas…
- FDA Drug
- Class III
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class III recall of Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Cas… by Contract Pharmaceuticals Canada, citing defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0364-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-02-20 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Contract Pharmaceuticals Canada |
| Distribution | US |
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
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Identifiers
| code_info | Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0364-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.