October 2013 FDA Recall Drug by Hi-tech Pharmacal Co., Inc.
D-389-2014 - Failed Stability Specification; product viscosity and or pH are below specification.

This Class III drug recall was voluntarily initiated by Hi-tech Pharmacal Co., Inc. on October 28, 2013 for the product Drug. The FDA reported the reason for recall as failed stability specification; product viscosity and or ph are below specification.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-389-2014

Reason for Recall
Failed Stability Specification; product viscosity and or pH are below specification.
Initiated
10-28-2013
Reported
01-01-2014
Quantity
51.948 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66675
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hi-Tech Pharmacal Co., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2016
Product Description About Product Description
Full technical description of the product.
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 or Lot Expiration Information

Batch# 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).