Recall record at a glance
| Official record | D-1520-1014 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medical Supply Liquidators LLC |
| Report date | Aug 13, 2014 |
| Recall initiation date | Jun 25, 2014 |
| Quantity | N/A |
| Location | Clive, IA, United States |
Official product description
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Why the product 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
Distribution information
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.