The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0164-2020·Announced 2019-11-06

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard
Affected units
7,293

Distribution

Distributed in 2 states:

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.

See all 2 products in this recall →

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