Neostigmine Methylsulfate Injection Solution — Class I drug recall D-0911-2018
Terminated recall by Fagron Compounding Services LLC dba Fagron Sterile Services, reported 2018-07-11, distributed nationwide. Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL m
| Recall number | D-0911-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron Compounding Services LLC dba Fagron Sterile Services, Wichita, KS, United States |
| Recall initiated | 2018-06-29 |
| Classified | 2018-07-06 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 390 prefilled |
| Reason classes | labeling, potency |
| NDC | 71266-2003-01 |
| Lot numbers | C274-000004678 |
| Expiration dates | 2018-09-20 |
Product
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
Reason for recall
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0911-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.