Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Product description
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
Lot numbers, UPCs & expiration codes
Lots: 8EE1702, 8EE1703, 8EE1704, 8FE1724, 8GE1942, 8HE1396, 8HE1397, 8JE2156, 8KE2521, 8KE2523, 8LE2255, 8LE2665, 8LE2668, 9AE2541, 9AE2542, 9AE2543, 9BE2993, 9BE2994, 9BE2995, 9CE3735, 9CE3736, 9DE3108, 9DE3109, 9DE3110, 9EE2872, 9EE2880, 9FE3273, 9FE3276, 9GE2978, 9GE2979, 9HE3437, 9HE3438
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-1024-2020
- 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-1024-2020, 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: 8EE1702, 8EE1703, 8EE1704, 8FE1724, 8GE1942, 8HE1396, 8HE1397, 8JE2156, 8KE2521, 8KE2523, 8LE2255, 8LE2665, 8LE2668, 9AE2541, 9AE2542, 9AE2543, 9BE2993, 9BE2994, 9BE2995, 9CE3735, 9CE3736, 9DE3108, 9DE3109, 9DE3110, 9EE2872, 9EE2880, 9FE3273, 9FE3276, 9GE2978, 9GE2979, 9HE3437, 9HE3438
- Postal code
- 49010-9070
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1024-2020
- 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, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 13, 2020