Why it was recalled
Subpotent drug: low fill volume in some of the capsules
Product description
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
Lot numbers, UPCs & expiration codes
Lot # 3097657, Exp 3/15
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-841-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 7, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 2,462 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi US
Original FDA data
Every field from FDA enforcement report D-841-2013, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65701
- Address
- 55 Corporate Dr
- Code information
- Lot # 3097657, Exp 3/15
- Postal code
- 08807-1265
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-841-2013
- Classification
- Class II
- Recalling firm
- Sanofi US
- Product quantity
- 2,462 bottles
- Termination date
- Mar 17, 2014
- Reason for recall
- Subpotent drug: low fill volume in some of the capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2013