Why it was recalled
Failed Impurities/Degradation specifications
Product description
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
Lot numbers, UPCs & expiration codes
Lot #: J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023
Where it was sold
Product was distributed to one account in PA.
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-0098-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2022
- FDA report date
- Jan 18, 2023
- Quantity
- 132 Cards of 30 = 3960 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0098-2023, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 91345
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023
- Postal code
- 15701-3571
- Report date
- Jan 18, 2023
- Product type
- Drugs
- Recall number
- D-0098-2023
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 132 Cards of 30 = 3960 Tablets
- Termination date
- Mar 3, 2023
- Reason for recall
- Failed Impurities/Degradation specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
- Distribution pattern
- Product was distributed to one account in PA.
- Recall initiation date
- Dec 20, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2023