WATER Recall D-0616-2021
Description: NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90
WATER Recall D-0616-2021 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0616-2021 |
Event ID | 87537 |
Brand | INSULIN DILUTING MEDIUM FOR NOVOLOG |
Generic Name | WATER INJECTION |
Manufacturer | WATER INJECTION |
Original Package? | 1 |
Active Substance | WATER |
Drug Route | INTRAVENOUS |
Distribution | Nationwide in the USA |
Recall Reason | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. |
Drug Classification | Class I |
Drug Code Info | 20210421 |
Product NDC | 0169-2001 0169-7501 0169-3303 |
Product NUI | M0011417 N0000175453 |
Pharma Class (EPC) | Insulin Analog [EPC] |
Pharma Class (CS) | Insulin [CS] |
Recall Initiation Date | 20210322 |
Report Date | 20210421 |
Classification Date | 20210610 |
Address | 800 Scudders Mill Rd Plainsboro, NJ 08536-1606 United States |
Recalling Firm | Novo Nordisk Inc |
Initial Notification | Letter |
Unique Ingredient Identifier | D933668QVX 059QF0KO0R |
Drug Application Number | BLA020986 |
Structured Product Labeling (SPL ID) | 7eb8d829-26ee-4a7a-8781-1f7fd6e3a832 |
Structured Product Labeling (SPL Set ID) | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 |
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