Food, drugs, devices › RemedyRepack Inc.
Drug recall: Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, ND
RemedyRepack Inc. (Indiana, PA) initiated this drug recall on 26 Oct 2018; FDA lists 1 product record under event 81554, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 5 Feb 2019. Initiation: voluntary: firm initiated. RemedyRepack Inc. has 36 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
RemedyRepack Inc., Indiana, PA.
Reason for recall
"Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing."
Distribution
"1 vial was distributed to a medical facility in Mayville, NY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0245-2019 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 | 1 vial | Class III | Terminated | 21 Nov 2018 |
Context
Other enforcement events for RemedyRepack Inc.
All 36 events for RemedyRepack Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "1 vial was distributed to a medical facility in Mayville, NY."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Feb 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.