Why it was recalled
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Product description
AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
Lot numbers, UPCs & expiration codes
Lot #: 52217, Expiry: 04/18
Where it was sold
U.S. Including: OH
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-1350-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 13, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 360 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1350-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 71980
- Address
- 150 Vintage Dr NE
- Code information
- Lot #: 52217, Expiry: 04/18
- Postal code
- 35811-8216
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1350-2015
- Classification
- Class III
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Product quantity
- 360 Bottles
- Termination date
- Aug 21, 2015
- Reason for recall
- Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
- Distribution pattern
- U.S. Including: OH
- Recall initiation date
- Aug 13, 2015
- Initial firm notification
- Telephone
- Center classification date
- Aug 20, 2015