Drug recall
Phenazopyridine HCl Tablets, USP 100mg, 100 and 1000 count bottles, Rx Only, Mfg. by: Able Laboratories, Inc…
FDA recall event 32132 · Class II · Able Laboratories, Inc.
Key facts
| Event ID | 32132 |
|---|---|
| Recall numbers | D-351-5, D-352-5, D-353-5 |
| Recalling firm | Able Laboratories, Inc. |
| Product type | Drugs |
| Products | Phenazopyridine HCl Tablets, USP 100mg, 100 and 1000 count bottles, Rx Only, Mfg. by: Able Laboratories, Inc., South Plainfield, NJ 07080 **** NDC 53265-196-10 and 53265-196-11 Also labeled as…, Phenazopyridine HCl Tablets, USP 200mg, 100 and 1000 count bottles, Mfg. by: Able Laboratories, Inc., South Plainfield, NJ 07080 **** NDC 53265-197-10 and 53265-197-11 Also labeled as Pyridium Tablets…, Phenazopyridine HCl Tablets, USP, 95 mg (Bulk). Mfg. by: Able Laboratories, Inc., South Plainfield, NJ 07080 for Polymedica Pharmaceuticals, Inc., Woburn, MA. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of assurance that testing conducted for release and stability conformed to standard operating procedures., There is lack of assurance that testing conducted for release and stability conformed to standard operating procedures. |
| Initiation date | May 25, 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