Why it was recalled
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Product description
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
Lot numbers, UPCs & expiration codes
Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01
Where it was sold
Product was shipped to the following states: CO, MA, OH, TX & WY.
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-1450-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2011
- FDA report date
- Jul 30, 2014
- Quantity
- 284/800 mg tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shamrock Medical Solutions Group LLC
Original FDA data
Every field from FDA enforcement report D-1450-2014, exactly as published.
Show all FDA fields
- City
- Lewis Center
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 64611
- Address
- 741 Radio Dr
- Code information
- Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01
- Postal code
- 43035-7134
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1450-2014
- Classification
- Class II
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Product quantity
- 284/800 mg tablets
- Termination date
- Jul 31, 2014
- Reason for recall
- Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Recall initiation date
- Sep 27, 2011
- Initial firm notification
- Telephone
- Center classification date
- Jul 23, 2014