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, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
Lot numbers, UPCs & expiration codes
Lots: 8AE1884, 8BE1466, 8DE1318, 8CE1617, 8DE1319, 8EE1326, 8DE1611, 8DE1767, 8FE1350, 8FE1352, 8GE1736, 8GE1840, 8GE1859, 8HE1592, 8HE1593, 8HE1594, 8JE2234, 9CE3263, 8JE2233, 8LE2360, 8KE2704, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3124, 9GE3122, 9HE3555
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-1023-2020
- 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-1023-2020, 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: 8AE1884, 8BE1466, 8DE1318, 8CE1617, 8DE1319, 8EE1326, 8DE1611, 8DE1767, 8FE1350, 8FE1352, 8GE1736, 8GE1840, 8GE1859, 8HE1592, 8HE1593, 8HE1594, 8JE2234, 9CE3263, 8JE2233, 8LE2360, 8KE2704, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3124, 9GE3122, 9HE3555
- Postal code
- 49010-9070
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1023-2020
- 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, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 13, 2020