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 |
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