FDA Drug recall D-1568-2014
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only
- FDA Drug
- Class I
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class I recall of Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only by Pharmakon Pharmaceuticals, citing incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1568-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-21 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | IL, IN, MD, TX |
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
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Identifiers
| code_info | Lot #: E0333282R; Exp: 7/13/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1568-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.