FDA-Drug2015-06-17Class II

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

Akorn, Inc.
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide including Puerto Rico
Affected count
N/A
Manufactured in
1925 W. Field Court, Suite 300, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1130-2015

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