June 2024 FDA Recall Drug by Zydus Pharmaceuticals (usa) Inc (D-0600-2024 - Presence of particulate matter)

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on June 27, 2024 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in TN and the recall is currently terminated.

Recall Number: D-0600-2024

Reason for Recall
Presence of particulate matter: glass
Initiated
06-27-2024
Reported
07-24-2024
Quantity
432250 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94914
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-04-2025
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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