Drug recall
Clorazepate Dipotassium Tablets, USP, 15mg, CIV, NDC 53265-050-10 (100s). Mfg. Able Laboratories, Inc., South…
FDA recall event 32116 · Class II · Able Laboratories, Inc.
Key facts
| Event ID | 32116 |
|---|---|
| Recall numbers | D-279-5, D-280-5, D-281-5 |
| Recalling firm | Able Laboratories, Inc. |
| Product type | Drugs |
| Products | Clorazepate Dipotassium Tablets, USP, 15mg, CIV, NDC 53265-050-10 (100s). Mfg. Able Laboratories, Inc., South Plainfield, NJ 07080, Clorazepate Dipotassium Tablets, USP, 3.75 mg, CIV, NDC 53265-048-10, (100s)Mfg. Able Laboratories, Inc., South Plainfield, NJ 07080., Clorazepate Dipotassium Tablets, USP, 7.5mg CIV, NDC 53265-049-10 and NDC 53265-049-50,(100s and 500s) Mfg. Able Laboratories Inc., South Plainfield, NJ 07080. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures. |
| Initiation date | May 24, 2005 |
| City | Cranbury |
| Country | United States |
| FEI number | 3004106764 |
At a glance
- 1–9 Products in this recall
- 1–9 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