Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination
Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant impurities like N-nitrosodimethylamine.
Plain-English summary
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. The product is identified by the NDC 11673-950-58 and is sold under the Up & Up brand. The recall covers specific lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, and 9JE2676.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The agency has classified this recall as Class II. The distribution pattern is listed as Nationwide USA.
Consumers who have purchased these specific lots of the product should stop using them and follow instructions from the recalling firm or their healthcare provider regarding disposal or return.
The recalled product
- Product
- Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Ranitidine
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 (7)
- Lots: 9BE3161
- 9CE3880
- 9EE2500
- 9FE2823
- 9GE2656
- 9HE3554
- 9JE2676
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 →Related recalls
Same manufacturer · Perrigo Company PLC
See all →- ModerateCareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateEquate Children's Pain and Fever Acetaminophen Suspension Recall
FDA (Drugs) · 2022-03-02
- ModerateEqualine Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateUP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateCVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02