Drug recall
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and…
FDA recall event 76641 · Class III · G & W Laboratories, Inc.
Key facts
| Event ID | 76641 |
|---|---|
| Recall numbers | D-0519-2017 |
| Recalling firm | G & W Laboratories, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. |
| Initiation date | Feb 28, 2017 |
| Report date | Mar 22, 2017 |
| Termination date | Dec 27, 2017 |
| City | South Plainfield |
| State | NJ |
| Country | United States |
| FEI number | 2210277 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: