Drug Enforcement D-0580-2024

Subpotent drug: out of specification results

Status

Ongoing

Classification

Class III

Report Date

July 10, 2024

Termination Date

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Product Information

Product description
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
Product quantity
52,998
Reason for recall
Subpotent drug: out of specification results
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
ACCORD HEALTHCARE, INC.
Address
1009 Slater Rd Ste 210B, N/A

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

Codes & Dates

Recall number
D-0580-2024
Event ID
94842
Recall initiation date
June 18, 2024
Center classification date
July 2, 2024
Code info
Lot# R2200834, R2200835, R2200841, R2200958, Exp 06/30/2024; R2201044 R2201045 R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, Exp 07/31/2024; M2215870, M2215918, Exp 10/2024
More code info
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