Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.

Recall Insight

This FDA Drug action (record #D-0519-2017) was formally reported on March 22, 2017, with the manufacturer initiating the action on February 28, 2017. It is classified under Low severity (Class III), with a current status of Terminated. G & W Laboratories, Inc. is listed as the recalling firm, operating out of South Plainfield, NJ. Federal records indicate 39,816 bottles units are affected.

The documented reason for this recall is: CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Distribution data in the federal record shows the product reached: Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.