Status
Terminated
Drug Enforcement D-389-2014
Failed Stability Specification; product viscosity and or pH are below specification.
Classification
Class III
Report Date
January 1, 2014
Termination Date
May 16, 2016
Product Information
- Product description
- 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.
- Product quantity
- 51.948 bottles
- Reason for recall
- Failed Stability Specification; product viscosity and or pH are below specification.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Address
-
369 Bayview Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-389-2014
- Event ID
- 66675
- Recall initiation date
- October 28, 2013
- Center classification date
- December 24, 2013
- 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).
- More code info
- —