D-0600-2024Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Terminated

Report date

2024-07-24

Distribution

Firm state

Product quantity

432250 vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

Presence of particulate matter: glass

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.

Code / lot info

Lot #: L200253, L200281, L200301, Exp 07/31/2024

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.