Why it was recalled
Lack of assurance of sterility
Product description
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
Lot numbers, UPCs & expiration codes
Lot # 07142015#7192@1, Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2015
Where it was sold
TX
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-0733-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 29, 2015
- FDA report date
- Mar 9, 2016
- Quantity
- 700 mL (7 vials of 100 mL)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TexasStar Pharmacy
Original FDA data
Every field from FDA enforcement report D-0733-2016, exactly as published.
Show all FDA fields
- City
- Plano
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72958
- Address
- 3033 W Parker Rd Ste 100
- Code information
- Lot # 07142015#7192@1, Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2015
- Postal code
- 75023-8000
- Report date
- Mar 9, 2016
- Product type
- Drugs
- Recall number
- D-0733-2016
- Classification
- Class II
- Recalling firm
- TexasStar Pharmacy
- Product quantity
- 700 mL (7 vials of 100 mL)
- Termination date
- Nov 17, 2016
- Reason for recall
- Lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
- Distribution pattern
- TX
- Recall initiation date
- Dec 29, 2015
- Initial firm notification
- Telephone
- Center classification date
- Mar 2, 2016