- Source
- FDA Enforcement Report
- Date
- Mar 25, 2020 (FDA report date)
- Filed by
- Perrigo Company PLC, Allegan, MI
- Class
- Class II
- Status
- Terminated (when we checked)
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Label text
- Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01
Who makes Kirkland Signature Maximum Strength Acid Reducer (ranitidine 150 mg)?
Allegan, MI · recalling firm · as of Mar 25, 2020
Sold by Costco under its Kirkland Signature label.
One Perrigo record lists the same tablet under Basic Care, Berkley Jensen, CVS Health, DG Health, Kirkland and Kroger. NDCs in the record: 63981-852-56 (Kirkland), 68391-852-56 (Berkley Jensen), 0113-7852-01 (Basic Care).
The record
Date checked: 2026-10-31. A record shows who made or recalled the product at that time. It does not prove who makes it today, and we never say a store-brand item is “the same” as a name brand unless a record says so.
More from Perrigo.
What the stamps mean
A record shows who made or recalled a product on that date. Suppliers change. How we check.
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