HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Reported: April 9, 2014 Initiated: January 31, 2014 #D-1189-2014
Product Description
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Reason for Recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 8,570 blister packs
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01. Recalled by American Health Packaging. Units affected: 8,570 blister packs.
Why was this product recalled? ▼
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 9, 2014. Severity: Moderate. Recall number: D-1189-2014.
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