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.
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 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 Exchang
- Manufacturer
- Perrigo Company PLC
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 →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
Same hazard · ndma contamination
See all →- SevereMetformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2022-02-02
- ModerateMetformin 750 mg Extended Release Recalled for NDMA Contamination
FDA (Drugs) · 2022-01-19
- HighMetformin Hydrochloride Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2021-06-30
- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA
FDA (Drugs) · 2020-11-25
- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA
FDA (Drugs) · 2020-07-08