Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Clindamycin Phosphate Topical Solution USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
What was recalled
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.
- Recalling firm
- G & W Laboratories, Inc.
- NDC code
- 0472-0987-91
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0519-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Clindamycin recalls
See all
Class III · Low risk Ongoing
Clindamycin Phosphate USP
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II · Moderate risk Ongoing
Clindamycin HCl Capsule
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Clindamycin HCl
Reason CGMP Deviations
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