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FDAFDA · Food and drugs·Recall number D-389-2014

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.

Published January 1, 2014 · Recall initiated: October 28, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Stability Specification; product viscosity and or pH are below specification.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Hi-Tech Pharmacal Co., Inc.
Distributor
Nationwide
Lot
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).
Risk classification
Class III
Area (FDA)
drug
Country
United States

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