← FDA ENFORCEMENT
D-0600-2024Class II
Zydus Pharmaceuticals (USA) Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Terminated
Report date
2024-07-24
Distribution
TN
Firm state
NJ
Product quantity
432250 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason 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
Data: U.S. FDA. 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. Open the enforcement explorer →