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.

FDA recall notice · announced May 8, 2013 · Hi-tech Pharmacal Co

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 610593, Exp 06/13
Quantity: 11,472 bottles
Status: Terminated
Products in this recall event:
- 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. (D-302-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.