Recalls / Class II
Class IID-1189-2014
Product
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
- Affected lot / code info
- Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14
Why it was recalled
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 8,570 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-31
- FDA classified
- 2014-04-03
- Posted by FDA
- 2014-04-09
- Terminated
- 2015-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1189-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.