Recalls / Class II
Class IID-1130-2015
Product
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
- Affected lot / code info
- Lot# 620984, 620987, Exp 04/2015; 621481, 621484, 621752, 621754 Exp 05/2015; 621875, 622239 Exp 06/2015; 622742, 622745, 623371 Exp 08/2015; 623374, 623820, 623823 Exp 09/2015; 624265, 624268 Exp 10/2015; 624824, 624827 Exp 11/2015; 625472, 625475 Exp 01/2016; 625783, 625786, 626447, 626450 02/2016; 627683, 627797 Exp 05/2016; 627800 Exp 06/2016; 629094, 629097, 629100, 629103 Exp 08/2016; 629928 Exp 09/2016; 629931, 630480, 630483 Exp 10/2016; 630874, 630877, 631513 Exp 12/2016
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2015-04-07
- FDA classified
- 2015-06-09
- Posted by FDA
- 2015-06-17
- Terminated
- 2017-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1130-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.