FDA Drug recall D-302-2013
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-8…
- FDA Drug
- Class III
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class III recall of Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-8… by Hi Tech Pharmacal, citing subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-302-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-03-11 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hi Tech Pharmacal |
| Distribution | US |
Product
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Reason
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Identifiers
| upc | 350383889151 |
|---|---|
| code_info | Lot #: 610593, Exp 06/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hi Tech Pharmacal
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal - Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal - FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
FDA Food · Class II · 2015-03-11 · Hi Tech Pharmacal - HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Ph…
FDA Drug · Class II · 2014-11-05 · Hi Tech Pharmacal - 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 · 2014-01-01 · Hi Tech Pharmacal
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-302-2013%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.