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Recall Observatory FDA recall evidence

Drug product

Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.

D-1523-2014

June 25, 2014

Class II

Product summary

Firm
Medical Supply Liquidators Llc
Event
Event 68626
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1523-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Code information: All lot numbers and exp dates

Distribution pattern: Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer