FDA Drug recall D-0609-2016
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON…
- FDA Drug
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON… by Pharmakon Pharmaceuticals, citing stability data does not support expiry.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0609-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-19 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | US |
Product
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason
Stability data does not support expiry.
Identifiers
| code_info | All lots with expiration dates up to 11/17/2015 |
|---|
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-0609-2016%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.