Drug recall
Amantadine Hydrochloride Capsules, USP, 100 mg, 100 and 500 count bottles, Rx only, manufactured by Actavis…
FDA recall event 48071 · Class II, Class III · Actavis Totowa LLC
Key facts
| Event ID | 48071 |
|---|---|
| Recall numbers | D-242-2008, D-243-2008, D-244-2008, D-245-208, D-246-2008, D-247-2008, D-248-2008, D-249-2008, D-250-2008, D-251-2008, D-252-2008, D-253-2008 and 7 more |
| Recalling firm | Actavis Totowa LLC |
| Product type | Drugs |
| Products | Amantadine Hydrochloride Capsules, USP, 100 mg, 100 and 500 count bottles, Rx only, manufactured by Actavis Totowa LLC, Totowa, NJ --- NDC 52152-309-02, 52152-309-04, Amidrine Capsules CAIV, USP, (Isometheptene Mucate, Dichloralphenazone and Acetaminophen), 65mg/100mg/325mg, in 100, 250 and 1000 count bottles, Rx only, Amide Pharmaceuticals, Little Falls, NJ…, Carisoprodol and Aspirin Tablets, USP 200 mg/325 mg, 100 count bottles, manufactured by Actavis Totowa LLC, Totowa, NJ ---- NDC 52152-137-02; 0037-2103-01 ---- Also labeled under Amide…, Chlordiazepoxide and Clidinium Bromide Capsules, 5mg/2.5mg, 100, 500 and 1000 capsule bottles, Rx only, Manufactured by Actavis Totowa LLC, Totowa, NJ ---- NDC 52152-018-02, 52152-018-04, 52152-18-05…, Glyburide (micronized) Tablets, USP; 1.5 mg, 100 count bottle, manufactured by Actavis Totowa, LLC, Totowa, NJ ---- NDC 52152-133-02 and 14 more |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | cGMP Deviations; lack of stability data to support expiry, Exceeded Impurity Specification, Subpotent; 18 month stability, Subpotent; 18month stability, Subpotent; acetaminophen and dichloralphenazone, Subpotent; carisoprodol, Subpotent; homatropine methylbromide, Superpotent; phentermine HCl, Superpotent, thiamine, Superpotent; thiamine |
| Initiation date | May 7, 2008 |
| Termination date | Dec 14, 2012 |
| City | Totowa |
| State | NJ |
| Country | United States |
| FEI number | 2244683 |
At a glance
- 10–99 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