CLASS III Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report
Clindamycin Phosphate Topical Solution recalled by G & W Laboratories
G & W Laboratories is recalling Clindamycin Phosphate Topical Solution USP, 1%, distributed nationwide in the US. The recall was initiated on 28 Feb 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0519-2017
- FDA event ID
- 76641
- Recalling firm
- G & W Laboratories, South Plainfield, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Feb 2017
- FDA classified
- 14 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 28 Feb 2017 | Recall initiated by company | |
| 14 Mar 2017 | Classified by FDA | +14 days |
| 22 Mar 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Which lots are affected?
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.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from G & W Laboratories
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|---|---|---|---|---|---|
| Drug | CLASS III | Ciclopirox Olamine Cream recalled by G & W LaboratoriesCiclopirox Olamine | G & W Laboratories | Packaging Defects | Nationwide |
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| Drug | CLASS II | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips recalled | G & W Laboratories | Potency & Assay | NJ |
| Drug | CLASS III | G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm recalledFluocinolone Acetonide | G & W Laboratories | Other | Nationwide |
Other Clindamycin recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |