Recalls / Class III
Class IIID-302-2013
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.
- Affected lot / code info
- Lot #: 610593, Exp 06/13
Why it was recalled
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Recalling firm
- Firm
- Hi-Tech Pharmacal Co., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 369 Bayview Ave, Amityville, New York 11701-2801
Distribution
- Quantity
- 11,472 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-03-11
- FDA classified
- 2013-04-30
- Posted by FDA
- 2013-05-08
- Terminated
- 2016-05-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-302-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.