Skip to content
Recall Observatory FDA recall evidence

Drug product

Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

D-1160-2018

August 21, 2018

Class II

Product summary

Firm
Auro Pharmacies, Inc.
Event
Event 80890
Status
Terminated
Classification
Class II
Quantity
114 vials
Official record key
drug-enforcement:D-1160-2018

Official wording

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Code information: Lot #: a) 180618/2, Exp 16-Sep-18; b) 180618/2, Exp 16-Sep-18

Distribution pattern: Nationwide in USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility