D-0919-2018 Class II Terminated
FDA drug recall D-0919-2018 was initiated by Medi-Fare Drug and Home Health Center on July 3, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. The recall status is terminated (terminated April 3, 2019). Affected quantity: 1116 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 18, 2018
- Initiation Date
- July 3, 2018
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1116 syringes
Product Description
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
Reason for Recall
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Distribution Pattern
Texas only
Code Information
Lot: 20180522@1 Exp.: 08/20/18