Baxter Healthcare Corporation: Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick,

Is my product affected?

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10

• Brand METOPROLOL

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling 402,165 vials of Metoprolol Tartrate Injection, USP (5 mg/5 mL), manufactured for Claris Lifesciences, Inc. The recall affects multiple lot numbers distributed nationwide in the USA and Puerto Rico, with expiration dates ranging from October 2018 through November 2019. The reason for the recall is that the pH of the solution in the affected lots shifted upward during the shelf life of the product, failing to meet required pH specifications.

The source document does not specify a remedy or what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

Details from the source

Reason for recall: Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. Distribution: Distributed nationwide in the USA and Puerto Rico Quantity: 402,165 vials Lot/code info: Lot #S: A061267, A061273,EXP 10/2018; A061392, A061395, A061398, A061403, A061407, EXP 11/2018; A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018; A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019; A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019; A0A0361, A0A0367, A0A0390, EXP 3/2019; A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019; A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019; A0A0777, EXP 7/2019; A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019; A0A1094, A0A1097, A0A1110, EXP 11/2019;

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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