Drug product
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007
D-0919-2018
Product summary
- Event
- Event 80453
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1116 syringes
- Official record key
drug-enforcement:D-0919-2018
Official wording
Reason: CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Code information: Lot: 20180522@1 Exp.: 08/20/18
Distribution pattern: Texas only
Derived failure modes
-
Manufacturing or process control
CGMP Deviations