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
Reported: March 6, 2013 Initiated: January 7, 2013 #D-170-2013
Product Description
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 for Recall
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Details
- Recalling Firm
- West-ward Pharmaceutical Corp.
- Units Affected
- 6,511 bottles
- Distribution
- Nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by West-ward Pharmaceutical Corp.. Units affected: 6,511 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 6, 2013. Severity: Moderate. Recall number: D-170-2013.
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