Why it was recalled
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Product description
Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
Lot numbers, UPCs & expiration codes
Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90
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-1446-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 27, 2011
- FDA report date
- Jul 30, 2014
- Quantity
- 89/120 mg tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shamrock Medical Solutions Group LLC
Original FDA data
Every field from FDA enforcement report D-1446-2014, 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
- Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90
- Postal code
- 43035-7134
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1446-2014
- Classification
- Class I
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Product quantity
- 89/120 mg tablets
- Termination date
- Jul 31, 2014
- Reason for recall
- Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
- 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