Baxter Recalls Metoprolol Tartrate Injection Due to pH Specification Failures
Baxter Healthcare is recalling 402,165 vials of Metoprolol Tartrate Injection because the solution's pH shifted upward during shelf life.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The hazard is a chemical specification failure (pH shift) with no reported injuries.
Plain-English summary
Baxter Healthcare Corporation is recalling 402,165 vials of Metoprolol Tartrate Injection, USP, 5 mg/5 mL (1 mg/mL). The product is a sterile single-use glass vial intended for intravenous use and is manufactured for Claris Lifesciences, Inc. The affected lots were distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to failed pH specifications, specifically an upward shift in the pH of the solution within the shelf life of the impacted lots. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions. The specific lot numbers and expiration dates are listed in the official recall documentation.
The recalled product
- Product
- METOPROLOL (METOPROLOL TARTRATE)
- Brand
- METOPROLOL
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Prescription Injection
- Affected units
- 402,165
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
UPCs (1)
- 0336000033107
Distribution
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