Why it was recalled
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Product description
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Lot numbers, UPCs & expiration codes
Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13
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-1411-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 6, 2012
- FDA report date
- Jul 18, 2012
- Quantity
- 54,431 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1411-2012, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 62496
- Address
- 120 Vintage Dr NE
- Code information
- Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13
- Postal code
- 35811-8216
- Report date
- Jul 18, 2012
- Product type
- Drugs
- Recall number
- D-1411-2012
- Classification
- Class III
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Product quantity
- 54,431 bottles
- Termination date
- Feb 1, 2013
- Reason for recall
- Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Jul 6, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2012