Aurobindo Ranitidine Capsules Recalled for NDMA Contamination
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 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 agency classification is FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the detection of a potential carcinogen (NDMA) in a prescription drug.
Plain-English summary
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg, 500 count bottles, which are distributed by Aurobindo Pharma USA, Inc. The recall involves 26,736 bottles of the prescription-only medication, identified by NDC 59651-144-05. The affected lots were distributed nationwide.
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 source text notes that NDMA has been detected in these forms of Ranitidine, prompting the specific recall of the Aurobindo capsules.
Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall covers specific lot codes and expiration dates ranging from July 2020 to May 2021, as listed in the product information.
The recalled product
- Product
- Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 26,736
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