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AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 3422917...

FDA Recall #D-0165-2020 — Class II — October 17, 2019

Recall #D-0165-2020 Date: October 17, 2019 Classification: Class II Status: Terminated

Product Description

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Reason for Recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Recalling Firm

AVKARE Inc. — Pulaski, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1351 bottles

Distribution

CO, MO

Code Information

Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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