Atropine Sulfate 0 — Class I drug recall D-1568-2014
Terminated recall by Pharmakon Pharmaceuticals, reported 2014-09-03, distributed in IL, IN, MD, TX. Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
| Recall number | D-1568-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmakon Pharmaceuticals, Noblesville, IN, United States |
| Recall initiated | 2014-04-21 |
| Classified | 2014-08-26 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2014-12-03 |
| Distributed | IL, IN, MD, TX |
| Quantity | 5 syringes |
| Reason classes | undeclared allergen |
| NDC | 45183-0105-78 |
| Lot numbers | E0333282R |
| Expiration dates | 2014-07-13 |
Product
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
Reason for recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
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-1568-2014. 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.