Drug Enforcement D-0600-2024

Presence of particulate matter: glass

Status

Terminated

Classification

Class II

Report Date

July 24, 2024

Termination Date

September 4, 2025

Product Information

Product description
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
Product quantity
432250 vials
Reason for recall
Presence of particulate matter: glass
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
TN

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0600-2024
Event ID
94914
Recall initiation date
June 27, 2024
Center classification date
July 16, 2024
Code info
Lot #: L200253, L200281, L200301, Exp 07/31/2024
More code info
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