Drug recall
Acetaminophen 325 mg/Phenylephrine HCl 5 mg/Chlorpheniramine Maleate 2 mg tablets, OTC, packed in bulk, net…
FDA recall event 47398 · Class III · A & Z Pharmaceutical, Inc.
Key facts
| Event ID | 47398 |
|---|---|
| Recall numbers | D-186-2008, D-187-2008, D-188-2008 |
| Recalling firm | A & Z Pharmaceutical, Inc. |
| Product type | Drugs |
| Products | Acetaminophen 325 mg/Phenylephrine HCl 5 mg/Chlorpheniramine Maleate 2 mg tablets, OTC, packed in bulk, net wt. 15.00 kg, and sold to one customer, A&Z Pharmaceutical, Inc., Children's Chewable Aspirin, 81 mg each, Pain Reliever/Fever Reducer, ORANGE FLAVOR, 36 Tablets, , OTC, Manufactured for Qualitest Pharmaceuticals, Inc. Huntsville, AL 35811 USA, Packed 24 bottles per…, Health A2Z Extra Strength PAIN RELIEF PM, Pain Reliever/Sleep Aid, Acetaminophen 500 mg and Diphenhydramine HCl 25 mg, 24 Caplets per bottle and in bulk, OTC, Manufactured by: A&Z Pharmaceutical Inc… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failure to validate manufacturing process; the products were re-worked without proper validation. |
| Initiation date | Mar 7, 2008 |
| Termination date | Aug 27, 2008 |
| City | Hauppauge |
| State | NY |
| Country | United States |
| FEI number | 3001195380 |
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