FDAClass IIINovember 21, 2018

Metoprolol Tartrate Injection recall

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

Why was Metoprolol Tartrate Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Recalling firm
RemedyRepack Inc.
Quantity
1 vial
Distribution
1 vial was distributed to a medical facility in Mayville, NY.
Recall date
November 21, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls