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Class II: temporary or reversible health riskTerminated

Perrigo Maximum Strength Acid Reducer Recall

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle

Perrigo Company PLC · Allegan, MI

Risk level
Class II
Reported by FDA
Mar 25, 2020
Recall ID
D-1018-2020
Check your lot numberHow we source this data

Summary

Perrigo recalled Maximum Strength Acid Reducer starting Oct 23, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1018-2020 on Mar 25, 2020. Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Status: Terminated.

Why it was recalled

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Product description

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

Lot numbers, UPCs & expiration codes

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

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-1018-2020
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-1018-2020, 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: 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
Postal code
49010-9070
Report date
Mar 25, 2020
Product type
Drugs
Recall number
D-1018-2020
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, 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
Distribution pattern
Nationwide USA
Recall initiation date
Oct 23, 2019
Initial firm notification
Press Release
Center classification date
Mar 13, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1018-2020, published Mar 25, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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