Drug 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.
D-389-2014
Product summary
- Event
- Event 66675
- Status
- Terminated
- Classification
- Class III
- Quantity
- 51.948 bottles
- Official record key
drug-enforcement:D-389-2014
Official wording
Reason: Failed Stability Specification; product viscosity and or pH are below specification.
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).
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specification