D-0245-2019 Class III Terminated
FDA drug recall D-0245-2019 was initiated by RemedyRepack Inc. on Oct 26, 2018 and is designated Class III. Reason for recall: Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. The recall status is terminated (terminated Feb 5, 2019). Affected quantity: 1 vial.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 21, 2018
- Initiation Date
- Oct 26, 2018
- Termination Date
- Feb 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 vial
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.
Distribution Pattern
1 vial was distributed to a medical facility in Mayville, NY.
Code Information
Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0245-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026