RemedyRepack Recalls Metoprolol Tartrate Injection Due to pH Failures
RemedyRepack Inc. is recalling specific lots of Metoprolol Tartrate Injection because stability testing showed high pH levels that failed specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a pH specification failure during stability testing, which falls under the 'Low' severity criteria for documentation or minor specification issues without reported harm.
Plain-English summary
RemedyRepack Inc. is recalling specific lots of Metoprolol Tartrate Injection, USP 5mg/5mL, vials. The recall was initiated because high out-of-specification results for pH were obtained during stability testing.
The affected product is a prescription-only medication manufactured by Claris Lifesciences Inc. and repacked by RemedyRepack Inc. The recall covers two specific lots: Lot A0A0253 (expiration 02/2019) and Lot B0369427-112717 (expiration 08/2019). The NDC number for the product is 70518-0868-00.
According to the source text, one vial was distributed to a medical facility in Mayville, NY. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or manufacturer for credit.
The recalled product
- Product
- Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 1
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 (4)
- Lot #: A0A0253
- Exp. 02/2019
- Lot #: B0369427-112717
- Exp. 08/2019
Distribution
Distribution scope not specified by the agency.
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