Reported Jan 1, 2014 · Terminated
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville,…
Hi-Tech Pharmacal Co., Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hi-Tech Pharmacal Co., Inc. · 369 Bayview Ave · Amityville, NY · 11701-2801
Is this the product you have?
- 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.
- Lot codes and dates
- 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)
- Batch no
- Amount recalled
- 51.948 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specification; product viscosity and or pH are below specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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