Why it was recalled
Failed Stability Specifications
Product description
TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
Lot numbers, UPCs & expiration codes
T248H15A, Exp. 08/17
Where it was sold
Nationwide
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-0326-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 22, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 1200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0326-2017, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 76087
- Address
- 150 Vintage Dr NE
- Code information
- T248H15A, Exp. 08/17
- Postal code
- 35811-8216
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0326-2017
- Classification
- Class III
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Product quantity
- 1200 bottles
- Termination date
- Sep 18, 2017
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 3, 2017