Recalls / Class II
Class IID-1529-2014
Product
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
- Affected lot / code info
- All lot numbers and exp dates
Why it was recalled
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
Recalling firm
- Firm
- Medical Supply Liquidators Llc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 10500 Hickman Rd Ste F, N/A, Clive, Iowa 50325-3706
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
Timeline
- Recall initiated
- 2014-06-25
- FDA classified
- 2014-08-06
- Posted by FDA
- 2014-08-13
- Terminated
- 2017-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1529-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.