Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Product description
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
Lot numbers, UPCs & expiration codes
Lots:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144
Where it was sold
Nationwide USA
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-1025-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 23, 2019
- FDA report date
- Mar 25, 2020
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-1025-2020, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 84127
- Address
- 515 Eastern Ave
- Code information
- Lots:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144
- Postal code
- 49010-9070
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1025-2020
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Termination date
- Nov 6, 2020
- Reason for recall
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 13, 2020