D-1391-2014 Class II Terminated
FDA drug recall D-1391-2014 was initiated by John W Hollis Inc on May 12, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. The recall status is terminated (terminated July 2, 2014). Affected quantity: 550 mL.
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
- 550 mL
Product Description
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, 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 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14