AvKare Recalls Ranitidine Capsules Due to NDMA Impurity
AvKare is recalling Ranitidine Hydrochloride Capsules 150 mg because N-nitrosodimethylamine (NDMA) was found in the active ingredient.
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 presence of NDMA, a known carcinogenic impurity, which aligns with the rubric criteria for Severe severity.
Plain-English summary
AvKare, Inc. is recalling 7,293 bottles of Ranitidine Hydrochloride Capsules 150 mg (NDC 42291-735-50). The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).
The affected product was distributed in Colorado and Missouri. The recall includes multiple lots with expiration dates ranging from November 30, 2019, to April 30, 2021. The FDA 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 and healthcare providers should stop using the recalled product and contact their healthcare provider for alternative treatment options. The product should be returned to the pharmacy or point of purchase for disposal or credit.
The recalled product
- Product
- AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 7,293
Distribution
Part of a larger recall action
This product is one of 2 recalled by AVKARE Inc. 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.
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