PlainRecalls
FDA Drug Moderate Class II Terminated

Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reported: June 25, 2014 Initiated: May 12, 2014 #D-1395-2014

Product Description

Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reason for Recall

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Details

Recalling Firm
John W Hollis Inc
Units Affected
1750 mL
Distribution
Nationwide
Location
Nashville, TN

Frequently Asked Questions

What product was recalled?
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234. Recalled by John W Hollis Inc. Units affected: 1750 mL.
Why was this product recalled?
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 25, 2014. Severity: Moderate. Recall number: D-1395-2014.