Drug 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.
D-302-2013
Product summary
- Event
- Event 65017
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,472 bottles
- Official record key
drug-enforcement:D-302-2013
Official wording
Reason: Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Code information: Lot #: 610593, Exp 06/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent