D-0654-2016 Class II Terminated
FDA drug recall D-0654-2016 was initiated by Fagron, Inc on November 11, 2015 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. The recall status is terminated (terminated August 22, 2017). Affected quantity: 44 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 17, 2016
- Initiation Date
- November 11, 2015
- Termination Date
- August 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 Bottles
Product Description
SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
Reason for Recall
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Distribution Pattern
Nationwide
Code Information
Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406