FDA Recall D-0364-2024
Contract Pharmaceuticals Limited Canada
Class III Ongoing 814 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Recall record
- Recall number
D-0364-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Recall initiated
- 2024-02-20
- Classified by FDA Center
- 2024-03-01
- FDA published
- 2024-03-13
- Recalling firm
- Contract Pharmaceuticals Limited Canada
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.