Why it was recalled
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Product description
Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
Lot numbers, UPCs & expiration codes
Lot # 3099036, Exp 03/2014
Where it was sold
Canada
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-886-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 998 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi-Synthelabo
Original FDA data
Every field from FDA enforcement report D-886-2013, exactly as published.
Show all FDA fields
- City
- Laval
- Status
- Terminated
- Country
- Canada
- Event ID
- 65954
- Address
- 2150 Boul Saint Elzear O
- Code information
- Lot # 3099036, Exp 03/2014
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-886-2013
- Classification
- Class II
- Recalling firm
- Sanofi-Synthelabo
- Product quantity
- 998 Bottles
- Termination date
- Jun 6, 2014
- Reason for recall
- Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
- Distribution pattern
- Canada
- Recall initiation date
- Feb 26, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2013