Drug recall
Prochlorperazine Suppository, USP, 2.5 mg. NDC 53265-243-12. 12 Pediatric-Size Suppositories. Able…
FDA recall event 32133 · Class II · Able Laboratories, Inc.
Key facts
| Event ID | 32133 |
|---|---|
| Recall numbers | D-340-5, D-341-5, D-342-5 |
| Recalling firm | Able Laboratories, Inc. |
| Product type | Drugs |
| Products | Prochlorperazine Suppository, USP, 2.5 mg. NDC 53265-243-12. 12 Pediatric-Size Suppositories. Able Laboratories, Inc., Prochlorperazine Suppository, USP, 25mg. NDC 53265-245-12. 12 Adult Suppositories. Note: Not for Use in Children. Mfg. Able Laboratories, Inc., Prochlorperazine Suppository, USP, 5mg. NDC 53265-244-12. 12 suppositories for Older Children (not under 40 lbs.) Mfg. Able Laboratories, Inc. |
| 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 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