G&W Laboratories Recalls Clindamycin Phosphate Topical Solution Due to Expired Ingredient
G&W Laboratories is recalling specific lots of Clindamycin Phosphate Topical Solution because an expired active ingredient was used during manufacturing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a manufacturing deviation involving an expired ingredient, with no reported injuries or illnesses.
Plain-English summary
G&W Laboratories, Inc. is recalling specific lots of Clindamycin Phosphate Topical Solution USP, 1%, packaged in 30 mL and 60 mL applicator bottles. The recall involves 39,816 bottles distributed nationwide in the United States. The product is distributed by Actavis Mid Atlantic LLC.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an expired active ingredient was used in the manufacture of the recalled lots. The affected lot numbers are 032100042, 032100043, 032100044, 032100045, 032100038, 032100039, 032100040, 032100041, 032100046, 032100047, 032100048, and 032100049.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates (05/17 or 06/17). If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement. No specific instructions for immediate consumer action beyond identifying the affected lots are provided in the source text.
The recalled product
- Product
- 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…
- Manufacturer
- G & W Laboratories, Inc.
- Category
- Drug — Topical Antibiotic
- Affected units
- 39,816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #'s: a) 032100042
- 032100043
- 032100044
- 032100045
- Exp 06/17
- b) 032100038
- 032100039
- 032100040
- 032100041
- Exp 05/17
- 032100046
- 032100047
- 032100048
- 032100049
- Exp 06/17.
Distribution
Distributed nationwide across the United States.
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