CYANOCOBALAMIN Recall D-0790-2022
Description: Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59
CYANOCOBALAMIN Recall D-0790-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0790-2022 |
| Event ID | 90003 |
| Brand | CYANOCOBALAMIN |
| Generic Name | CYANOCOBALAMIN |
| Manufacturer | CYANOCOBALAMIN |
| Original Package? | 1 |
| Active Substance | CYANOCOBALAMIN |
| Drug Route | INTRAMUSCULAR |
| Distribution | Alabama |
| Quantity | 97,975 vials |
| Recall Reason | Subpotent Drug: Out of specification for assay. |
| Drug Classification | Class III |
| Drug Code Info | 20220504 |
| Product NDC | 68001-509 |
| Product NUI | M0022794 N0000175951 |
| Drug UPC | 0368001509596 |
| Pharma Class (EPC) | Vitamin B12 [EPC] |
| Pharma Class (CS) | Vitamin B 12 [CS] |
| Recall Initiation Date | 20220412 |
| Report Date | 20220504 |
| Classification Date | 20220426 |
| Address | 2550 John Glenn Ave Ste A Columbus, OH 43217-1188 United States |
| Recalling Firm | American Health Packaging |
| Initial Notification | Letter |
| Unique Ingredient Identifier | P6YC3EG204 |
| Drug Application Number | ANDA213874 |
| Structured Product Labeling (SPL ID) | d2918bb9-c46b-3bf8-e053-2995a90adc92 |
| Structured Product Labeling (SPL Set ID) | 034615bb-9f98-4034-b3a2-b1cc22a00a46 |
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