Drug Enforcement D-0528-2023

Sub-potent drug: assay test result below specifications at 9-month timepoint.

Status

Terminated

Classification

Class III

Report Date

April 12, 2023

Termination Date

March 19, 2025

Product Information

Product description
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.
Product quantity
4574 cartons
Reason for recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA.

Location & Firm

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

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

Codes & Dates

Recall number
D-0528-2023
Event ID
91977
Recall initiation date
March 29, 2023
Center classification date
April 6, 2023
Code info
Lot #: R2200394 Exp. 03/2024
More code info
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