Why it was recalled
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
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
Lot numbers, UPCs & expiration codes
Lot: 20180522@1 Exp.: 08/20/18
Where it was sold
Texas only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0919-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 3, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 1116 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medi-Fare Drug and Home Health Center
Original FDA data
Every field from FDA enforcement report D-0919-2018, exactly as published.
Show all FDA fields
- City
- Blacksburg
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 80453
- Address
- 300 W Pine St
- Code information
- Lot: 20180522@1 Exp.: 08/20/18
- Postal code
- 29702-1548
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0919-2018
- Classification
- Class II
- Recalling firm
- Medi-Fare Drug and Home Health Center
- Product quantity
- 1116 syringes
- Termination date
- Apr 3, 2019
- Reason for recall
- CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Texas only
- Recall initiation date
- Jul 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2018