October 2018 FDA Recall Drug by Remedyrepack Inc.
D-0245-2019 - Failed pH Specifications
This Class III drug recall was voluntarily initiated by Remedyrepack Inc. on October 26, 2018 for the product Drug. The FDA reported the reason for recall as failed ph specifications. The product was distributed in 1 vial was distributed to a medical facility in Mayville, NY. and the recall is currently terminated.
Recall Number: D-0245-2019
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
10-26-2018
11-21-2018
1 vial
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
1 vial was distributed to a medical facility in Mayville, NY.
02-05-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Batch or Lot Expiration Information
Lot# : A0A0253, Exp. 02/2019
Lot# : B0369427-112717, Exp. 08/2019
