Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Product description
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09
Lot numbers, UPCs & expiration codes
Lots: 8AE1752, 8BE1412, 8CE1437, 8CE1439, 8DE1141, 8DE1737, 8EE1318, 8FE1690, 8GE1928, 8HE1395, 8JE2155, 8KE2516, 8LE2253, 8LE2624, 9AE2522, 9BE2933, 9BE2934, 9CE3734, 9DE3070, 9EE2830, 9FE3266, 9GE2934
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-1022-2020
- 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-1022-2020, 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: 8AE1752, 8BE1412, 8CE1437, 8CE1439, 8DE1141, 8DE1737, 8EE1318, 8FE1690, 8GE1928, 8HE1395, 8JE2155, 8KE2516, 8LE2253, 8LE2624, 9AE2522, 9BE2933, 9BE2934, 9CE3734, 9DE3070, 9EE2830, 9FE3266, 9GE2934
- Postal code
- 49010-9070
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1022-2020
- 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, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 13, 2020