FDA Drug recall D-1290-2016
Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL
- FDA Drug
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL by Pharmakon Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1290-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-20 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | US |
Product
Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All Sterile Compounded Products within Expiry |
|---|
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-1290-2016%22
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