D-1394-2014 Class II Terminated

Recalled by John W Hollis Inc — Nashville, TN

Recall Details

Product Type
Drugs
Report Date
June 25, 2014
Initiation Date
May 12, 2014
Termination Date
July 2, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2250 mL

Product Description

Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 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.

Distribution Pattern

Nationwide

Code Information

Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14