FDA Drug recall D-389-2014
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc
- FDA Drug
- Class III
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class III recall of Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc by Hi Tech Pharmacal, citing failed Stability Specification; product viscosity and or pH are below specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-389-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-10-28 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hi Tech Pharmacal |
| Distribution | US |
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
Failed Stability Specification; product viscosity and or pH are below specification.
Identifiers
| 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) 6…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-389-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.