Agency classClass IIOur severity:Severe FDA (Drugs)·D-1018-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling Maximum Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from N-nitrosodimethylamine contamination.

Plain-English summary

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. The recall involves multiple store brands and NDC codes, including Being Well, Care One, CVS Health, DG Health, Equaline, Equate, and others. The products were distributed nationwide in the United States.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine (NDMA). The source text does not specify the exact number of affected units or specific lot numbers beyond the provided list.

Consumers who have purchased these products should check their bottles for the affected NDC codes and lot numbers. If the product matches the description, consumers should stop using it and contact their pharmacist or the recalling firm for instructions on disposal or return.

The recalled product

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…
Manufacturer: Perrigo Company PLC
Category: Drug — Prescription/OTC Medication
Hazard: ndma-contamination
cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lots: 8EE1452R
8AE1743
8BE1340
8CE1549
8CE1778
8DE1128
8DE1313
8DE1640
8EE1117
8EE1234
8EE1452
8CE1314
8CE1315
8DE1096
8DE1530
8EE1699
8GE1528
8HE1465
8JE2199
8LE2172

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Perrigo Company PLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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Same hazard · ndma contamination