Recalls / Class II
Class IID-1160-2018
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
- Affected lot / code info
- Lot #: a) 180618/2, Exp 16-Sep-18; b) 180618/2, Exp 16-Sep-18
Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Recalling firm
- Firm
- Auro Pharmacies, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 520 W La Habra Blvd, N/A, La Habra, California 90631-5308
Distribution
- Quantity
- 114 vials
- Distribution pattern
- Nationwide in USA
Timeline
- Recall initiated
- 2018-08-21
- FDA classified
- 2018-08-29
- Posted by FDA
- 2018-09-05
- Terminated
- 2020-01-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1160-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.