CYANOCOBALAMIN Recall D-0766-2022
Description: Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
CYANOCOBALAMIN Recall D-0766-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0766-2022 |
| Event ID | 89941 |
| Brand | CYANOCOBALAMIN |
| Generic Name | CYANOCOBALAMIN |
| Manufacturer | CYANOCOBALAMIN |
| Original Package? | 1 |
| Active Substance | CYANOCOBALAMIN |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA. |
| Quantity | 433,809 vials |
| Recall Reason | Subpotent Drug: Out of Specification results for Assay |
| Drug Classification | Class III |
| Drug Code Info | 20220420 |
| Product NDC | 55150-364 |
| Product NUI | M0022794 N0000175951 |
| Drug UPC | 0355150364015 |
| Pharma Class (EPC) | Vitamin B12 [EPC] |
| Pharma Class (CS) | Vitamin B 12 [CS] |
| Recall Initiation Date | 20220405 |
| Report Date | 20220420 |
| Classification Date | 20220412 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Aurobindo Pharma USA Inc. |
| Unique Ingredient Identifier | P6YC3EG204 |
| Drug Application Number | ANDA213874 |
| Structured Product Labeling (SPL ID) | 96dcbbb3-27d4-4ab9-aa0a-2fd2ebba6a8c |
| Structured Product Labeling (SPL Set ID) | db84d0ea-5c15-47f5-bbe2-8d455e75695e |
| Similar To |