FDA Drug Low Class III Terminated

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.

Reported: January 1, 2014 Initiated: October 28, 2013 #D-389-2014

Product Description

Reason for Recall

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

Details

Recalling Firm: Hi-Tech Pharmacal Co., Inc.
Units Affected: 51.948 bottles
Distribution: Nationwide
Location: Amityville, NY

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 51.948 bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on January 1, 2014. Severity: Low. Recall number: D-389-2014.

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