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.

FDA recall notice · announced January 1, 2014 · Hi-tech Pharmacal Co

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/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).
Quantity: 51.948 bottles
Status: Terminated
Products in this recall event:
- 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. (D-389-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.