Drug recall
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC…
FDA recall event 65844 · Class II · West-Ward Pharmaceutical Corp.
Key facts
| Event ID | 65844 |
|---|---|
| Recall numbers | D-883-2013 |
| Recalling firm | West-Ward Pharmaceutical Corp. |
| Product type | Drugs |
| Products | Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets |
| Initiation date | Jul 30, 2013 |
| Report date | Aug 21, 2013 |
| Termination date | Jun 23, 2014 |
| City | Eatontown |
| State | NJ |
| Country | United States |
| FEI number | 2250102 |
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 · Source date: