AuroMedics Recalls Ranitidine Tablets Due to NDMA Detection
AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
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 and involves the detection of NDMA, a potential carcinogen, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risk).
Plain-English summary
AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count cartons. The recall involves 69,696 bottles distributed nationwide by Dolgencorp LLC. The specific lot number is NBSB19001DA3 with an expiration date of February 2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of N-nitrosodimethylamine (NDMA) in Ranitidine tablets, capsules, and syrups. The FDA has classified this recall as Class II.
Consumers who have purchased this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on alternatives or disposal.
The recalled product
- Product
- DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
- Manufacturer
- AuroMedics Pharma LLC
- Affected units
- 69,696
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 (2)
- Lot # NBSB19001DA3
- Exp FEB 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by AuroMedics Pharma LLC 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 5 products in this recall →Related recalls
Same manufacturer · AuroMedics Pharma LLC
See all →- HighFondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
FDA (Drugs) · 2022-11-02
- HighAcyclovir Sodium Injectable Recalled for Particulate Matter
FDA (Drugs) · 2022-10-26
- LowTranexamic Acid Injection Recalled for Metal Particulate Matter
FDA (Drugs) · 2022-10-12
- SeverePolymyxin B for Injection Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2022-02-16
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
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