Multi-event October 2019 FDA Recall Drug by Perrigo Company Plc

This Multi-event Class II drug recall was voluntarily initiated by Perrigo Company Plc on October 23, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation; possible contamination with impurity n-nitrosodimethylamine.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1017-2020 TERMINATED D-1026-2020 TERMINATED D-1015-2020 TERMINATED D-1023-2020 TERMINATED D-1027-2020 TERMINATED D-1028-2020 TERMINATED D-1020-2020 TERMINATED D-1024-2020 TERMINATED D-1025-2020 TERMINATED D-1022-2020 TERMINATED D-1021-2020 TERMINATED D-1019-2020 TERMINATED D-1018-2020 TERMINATED D-1016-2020 TERMINATED D-1014-2020 TERMINATED D-1012-2020 TERMINATED D-1013-2020 TERMINATED

Recall Number: D-1017-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51

Batch or Lot Expiration Information

Lot# Lots: 8CE1429, 8CE1760, 9BE2907, 9DE3183, 9EE2900, 9JE2936

Recall Number: D-1026-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lots:8CE1446, 8DE1740, 8FE1238, 8FE1794, 8GE1964, 8JE2159, 8ME2546, 8ME2547, 9BE3011, 9CE3854, 9DE3158, 9FE3340, 9HE3445, 9JE2663, 8AE1779, 8BE1414, 8DE1199, 8DE1200, 8DE1532, 8EE1321, 8FE1239, 8FE1346, 8FE1793, 8HE1516, 8KE2563, 8KE2563R, 8LE2260, 9AE2610, 9AE2612, 9BE3012, 9BE3013, 9CE3852, 9DE3156R, 9DE3160, 9DE3161, 9EE2952, 9FE3338, 9GE2993, 8AV1095, 8AV1150, 8AV1235, 8AV1236, 8AV1237, 8BV0896, 8BV0897, 8BV0910, 8BV1737, 8BV1757, 8BV1758, 8CV0930, 8CV1316, 8CV1317, 8CV1319, 8CV1324, 8CV1633, 8DV1128, 8DV1129, 8DV1134, 8EV0993, 8EV0994, 8EV0995, 8EV1240, 8FV0712, 8FV0912, 8FV0913, 8FV0914, 8FV0915, 8GV0847, 8GV0849, 8GV0997, 8HV0926, 8HV0928, 8HV1534, 8HV1535, 8JV0730, 8JV0944, 8KV2339, 8KV2348, 8KV2485, 8LV1791, 8LV2205, 8MV1650, 8MV1712, 9AV2395, 9AV2679, 9AV2680, 9BV2182, 9CV1345, 9CV1346, 9CV1347, 9CV1348, 9CV1349, 9DV1511, 9DV1515, 9EV1422, 9EV1585, 9EV1596, 9FV1132, 9FV1275R, 9FV1330, 9FV1331, 9FV1332, 9FV1333, 9FV1339, 9FV1954, 9FV1972, 9GV1675, 9GV1994, 9HV1415

Recall Number: D-1015-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47

Batch or Lot Expiration Information

Lot# Lots: 8CE1644, 8CE1645, 8DE1401, 8DE1402, 8DE1403, 8DE1769, 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229

Recall Number: D-1023-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1027-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01

Batch or Lot Expiration Information

Lot# Lots: 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202

Recall Number: D-1028-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82

Batch or Lot Expiration Information

Lot# Lots: 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE2161, 8KE2565, 8LE2261, 8ME2548, 9AE2658, 9BE3018, 9CE3861, 9DE3244, 9FE2820, 9FE3373, 9GE3094, 9HE3449, 9JE2665

Recall Number: D-1020-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58

Batch or Lot Expiration Information

Lot# Lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, 9JE2676

Recall Number: D-1024-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1025-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75

Batch or Lot Expiration Information

Lot# Lots:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144

Recall Number: D-1022-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lots: 8AE1752, 8BE1412, 8CE1437, 8CE1439, 8DE1141, 8DE1737, 8EE1318, 8FE1690, 8GE1928, 8HE1395, 8JE2155, 8KE2516, 8LE2253, 8LE2624, 9AE2522, 9BE2933, 9BE2934, 9CE3734, 9DE3070, 9EE2830, 9FE3266, 9GE2934

Recall Number: D-1021-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71

Batch or Lot Expiration Information

Lot# Lots: 8AE1744, 8BE1369, 8CE1377, 8CE1378, 8DE1103, 8DE1531, 8EE1700, 8FV0829, 8DE1722, 8EE1317, 8FE1635, 8GE1921, 8HE1342, 8KE2503R, 8JE2154, 8KE2503, 8LE2198, 8LE2597, 9AE2499, 9BE2862, 9BE2863, 9CE3723, 9DE2890, 9DE2891, 9EE2812, 9FE3187, 9GE2885, 9HE3435, 9JE2656

Recall Number: D-1019-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02

Batch or Lot Expiration Information

Lot# Lots: 8FV1462, 8GV1289, 8BE1465, 8CE1616, 8DE1277, 8DE1580, 8DE1766, 8FE1348, 8GE1527, 8GE1733, 8GE1735, 8HE1466, 8HE1590, 8JE2232, 8KE2676, 8LE2283, 8LE2284, 8LE2345, 8ME2640, 9AE2663, 9AE2863, 9AE2864, 9BE3158, 9CE3773, 9CE3774, 9CE3879, 9EE2499, 9EE2635, 9EE2904, 9FE2821, 9FE2953, 9FE3369, 9GE2653, 9GE2905, 9GE3077, 9GE3115, 9HE3546, 9HE3559, 9JE2593

Recall Number: D-1018-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1016-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06

Batch or Lot Expiration Information

Lot# Lots: 8FE1455, 8GE1343, 8HE1225, 8KE2834, 8KE2249, 8ME2730, 9AE2838, 9EE2639, 9FE2993

Recall Number: D-1014-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27

Batch or Lot Expiration Information

Lot# Lots: 8CE1643, 8DE1370, 8DE1768, 8EE1560, 8FE1452, 8GE1341, 8HE1223, 8KE2832, 8KE2246, 8ME2725, 9AE2835, 9CE3378, 9DE2748, 9EE2637, 9FE2976, 9GE2795, 9GE3228, 9HE3617

Recall Number: D-1012-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65

Batch or Lot Expiration Information

Lot# Lots: 8DE1363, 8EE1558, 8FE1450, 8GE1331, 8HE1221, 8KE2825, 8JE1916, 8KE2243, 8ME2685, 9AE2785, 9AE2786, 9DE2721, 9CE3317, 9EE2579, 9FE2957, 9GE2785, 9GE3218, 9HE3577

Recall Number: D-1013-2020

Reason for Recall
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Initiated
10-23-2019
Reported
03-25-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;

Batch or Lot Expiration Information

Lot# Lots: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245 , 8ME2724, 9AE2831, 9DE2747, 9CE3339, 9EE2636, 9FE2971, 9GE2793, 9GE3220