Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal...
FDA Recall #D-389-2014 — Class III — October 28, 2013
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.
Reason for Recall
Failed Stability Specification; product viscosity and or pH are below specification.
Recalling Firm
Hi-Tech Pharmacal Co., Inc. — Amityville, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
51.948 bottles
Distribution
Nationwide
Code Information
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).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated