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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 66675
Product Type Drugs
Status Ongoing
Recalling Firm Hi-Tech Pharmacal Co., Inc.
City Amityville
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-28
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16. Batch no: 1) 614463 (exp. 03/2014), 2) 612905 (exp. 12/2013), 3) 614923 (exp. 03/2014), 4) 615852 (exp. 05/2014), 5) 615855 (exp. 05/2014), 6) 616689 (exp. 07/2014), 7) 616692 (exp. 07/2014). Class II Failed Stability Specification; product viscosity and or pH are below specification. 51.948 bottles D-389-2014
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