Agency classClass IIOur severity:Severe FDA (Drugs)·D-1017-2020·Announced 2020-03-25

Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 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 and involves potential contamination with N-nitrosodimethylamine, a known carcinogen, which meets the rubric criteria for a Severe rating.

Plain-English summary

Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. The recall involves specific product lots identified by the codes 8CE1429, 8CE1760, 9BE2907, 9DE3183, 9EE2900, and 9JE2936. The products are distributed nationwide in the United States under the NDC codes 0113-0852-51 (Good Sense) and 0363-0852-51 (Walgreens).

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased these specific lots of Ranitidine tablets should stop using them and contact their pharmacist or the recalling firm for further instructions. This recall is limited to the specific lot numbers and NDC codes listed above.

The recalled product

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
Manufacturer: Perrigo Company PLC
Category: Drug — Ranitidine
Hazard: nitrosamine-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 (6)

Lots: 8CE1429
8CE1760
9BE2907
9DE3183
9EE2900
9JE2936

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 · nitrosamine contamination