Recalls / Class II
Class IID-1018-2020
Product
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62
- Affected lot / code info
- Lots: 8EE1452R, 8AE1743, 8BE1340, 8CE1549, 8CE1778, 8DE1128, 8DE1313, 8DE1640, 8EE1117, 8EE1234, 8EE1452, 8CE1314, 8CE1315, 8DE1096, 8DE1530, 8EE1699, 8GE1528, 8HE1465, 8JE2199, 8LE2172, 8DE1721, 8EE1299, 8FE1634, 8GE1833, 8GE1835, 8HE1337, 8LE2173, 8LE2380, 9BE2888, 8JE2162, 8KE2495, 8KE2496, 8LE2169, 9BE2772, 9BE2889, 9CE3771, 9DE2854, 8LE2288, 8LE2592, 8LE2593, 8ME3124, 8ME3125, 9BE2773, 9BE2774, 9DE3234, 9EE2603, 9EE2903, 9FE2952, 9CE3689, 9CE3690, 9EV1891, 9FV1152, 9DE2868, 9DE2869, 9EE2760, 9FV1153, 9EE2779, 9GE2879, 9HE3558, 9JE2591, 9FE3109, 9FE3110, 9GE2869, 9HE3433, 9JE2541
Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm
- Firm
- Perrigo Company PLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-10-23
- FDA classified
- 2020-03-13
- Posted by FDA
- 2020-03-25
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1018-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.