Status
Terminated
Drug Enforcement D-302-2013
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Classification
Class III
Report Date
May 8, 2013
Termination Date
May 13, 2016
Product Information
- Product description
- 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.
- Product quantity
- 11,472 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Address
-
369 Bayview Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-302-2013
- Event ID
- 65017
- Recall initiation date
- March 11, 2013
- Center classification date
- April 30, 2013
- Code info
- Lot #: 610593, Exp 06/13
- More code info
- —