Why it was recalled
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Product description
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Lot numbers, UPCs & expiration codes
Code 1661911; Batch 1340; Exp. 03/17
Where it was sold
Product distributed solely to the state of Minnesota.
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-0447-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 20, 2014
- FDA report date
- Feb 1, 2017
- Quantity
- 2351.12 pound container
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cambrex Charles City Inc
Original FDA data
Every field from FDA enforcement report D-0447-2017, exactly as published.
Show all FDA fields
- City
- Charles City
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 76166
- Address
- 1205 11th St
- Code information
- Code 1661911; Batch 1340; Exp. 03/17
- Postal code
- 50616-3466
- Report date
- Feb 1, 2017
- Product type
- Drugs
- Recall number
- D-0447-2017
- Classification
- Class II
- Recalling firm
- Cambrex Charles City Inc
- Product quantity
- 2351.12 pound container
- Termination date
- Mar 9, 2017
- Reason for recall
- Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
- Distribution pattern
- Product distributed solely to the state of Minnesota.
- Recall initiation date
- May 20, 2014
- Center classification date
- Jan 26, 2017