Why it was recalled
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Product description
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Lot numbers, UPCs & expiration codes
Lot #A200170, exp. date December 2023
Where it was sold
Product was distributed 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-1343-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 28, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 7,872/30 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1343-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 90616
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #A200170, exp. date December 2023
- Postal code
- 21202-6174
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1343-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 7,872/30 count bottles
- Termination date
- Oct 5, 2023
- Reason for recall
- CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Jul 28, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2022