The Recall Desk
SevereFDA (Drugs)·D-0165-2020·Announced 2019-11-06

AVKARE Recalls Ranitidine Hydrochloride Capsules Due to NDMA Impurity

AVKARE Inc. is recalling Ranitidine Hydrochloride Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA). The affected bottles were distributed in Colorado and Missouri.

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. The presence of NDMA, a potential carcinogen, in a prescription medication represents a significant health risk, justifying the higher severity score despite the lack of reported injuries in the source text.

Plain-English summary

AVKARE Inc. is recalling 1,351 bottles of Ranitidine Hydrochloride Capsules 300 mg (500 capsules per bottle). The recall was initiated 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 is identified by NDC 42291-736-50 and UPC 342291736504. The recall covers five specific lots: Lot 17709 (Exp. 01/31/2020), Lot 18460 (Exp. 02/29/2020), Lot 19853 (Exp. 09/30/2020), Lot 22362 (Exp. 11/30/2020), and Lot 22579 (Exp. 11/30/2020). The product was distributed in Colorado and Missouri.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or credit, in accordance with standard recall procedures.

The recalled product

Product
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,351

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 →

Related recalls

Same manufacturer · AVKARE Inc.

See all →

Same hazard · ndma impurity

See all →