WATER Recall D-0615-2021
Description: NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit)
WATER Recall D-0615-2021 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0615-2021 |
| 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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