Recalls / Class III
Class IIID-389-2014
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.
- Affected lot / code info
- 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).
Why it was recalled
Failed Stability Specification; product viscosity and or pH are below specification.
Recalling firm
- Firm
- Hi-Tech Pharmacal Co., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 369 Bayview Ave, N/A, Amityville, New York 11701-2801
Distribution
- Quantity
- 51.948 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-28
- FDA classified
- 2013-12-24
- Posted by FDA
- 2014-01-01
- Terminated
- 2016-05-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-389-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.