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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description 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.
Recall Number D-389-2014
Classification Class II
Code Info 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).
Product Distributed Qty 51.948 bottles
Reason For Recall Failed Stability Specification; product viscosity and or pH are below specification.

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
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