FDA Drug recall D-170-2013
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg
- FDA Drug
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg by West Ward Pharmaceutical, citing presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-170-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-07 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceutical |
| Distribution | US |
Product
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Reason
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Identifiers
| code_info | Lot #: 69099A, 69099B, Exp 08/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-170-2013%22
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