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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 610593, Exp 06/13
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-302-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2013
- FDA report date
- May 8, 2013
- Quantity
- 11,472 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
Original FDA data
Every field from FDA enforcement report D-302-2013, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65017
- Address
- 369 Bayview Ave
- Code information
- Lot #: 610593, Exp 06/13
- Postal code
- 11701-2801
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-302-2013
- Classification
- Class III
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Product quantity
- 11,472 bottles
- Termination date
- May 13, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 30, 2013