D-1398-2014 Class II Terminated
FDA drug recall D-1398-2014 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: 30 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
- 30 mL
Product Description
B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 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 # 2095, Use by 8/17/14