Drug Enforcement D-0341-2024

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Status

Ongoing

Classification

Class II

Report Date

February 28, 2024

Termination Date

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Product Information

Product description
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
Product quantity
421 vials involved in this recall (2,448 vials distributed)
Reason for recall
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Mallinckrodt Hospital Products Inc.
Address
440 Us Highway 22, Ste 302

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0341-2024
Event ID
93945
Recall initiation date
February 6, 2024
Center classification date
February 21, 2024
Code info
Lot #: 22TRP01-F2, Exp 6/30/2024
More code info
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