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.
Reported: May 8, 2013 Initiated: March 11, 2013 #D-302-2013
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.
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.
Details
- Recalling Firm
- Hi-Tech Pharmacal Co., Inc.
- Units Affected
- 11,472 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Amityville, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 11,472 bottles.
Why was this product recalled? ▼
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2013. Severity: Low. Recall number: D-302-2013.
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