Why it was recalled
CGMP Deviations
Product description
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
Lot numbers, UPCs & expiration codes
Lot # X223FS; Exp. 11/17
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-1040-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2016
- FDA report date
- Jun 29, 2016
- Quantity
- 31 boxes ( 372 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Profarma Distributors LLC
Original FDA data
Every field from FDA enforcement report D-1040-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 74135
- Address
- 4751 Poth Rd
- Code information
- Lot # X223FS; Exp. 11/17
- Postal code
- 43213-1331
- Report date
- Jun 29, 2016
- Product type
- Drugs
- Recall number
- D-1040-2016
- Classification
- Class II
- Recalling firm
- Profarma Distributors LLC
- Product quantity
- 31 boxes ( 372 capsules)
- Termination date
- Jan 24, 2017
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- tabcin NOCHE; Capsules,12-count box, UPC 501008485033
- Distribution pattern
- Nationwide
- Recall initiation date
- May 11, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2016