RecallRadar

FDA Drug recall D-0245-2019

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

On 2018-11-21 the FDA classified a Class III recall of Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 by Remedyrepack, citing failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0245-2019
ClassificationClass III
Statusterminated
Initiated2018-10-26
Published2018-11-21
Last updated2026-09-13 11:52 UTC
CompanyRemedyrepack
DistributionNY

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0245-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.