Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North ...

FDA Recall #D-0245-2019 — Class III — October 26, 2018

Recall #D-0245-2019 Date: October 26, 2018 Classification: Class III Status: Terminated

Product Description

Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00

Reason for Recall

Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.

Recalling Firm

RemedyRepack Inc. — Indiana, PA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1 vial

Distribution

1 vial was distributed to a medical facility in Mayville, NY.

Code Information

Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019

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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