Drug product
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.
D-0654-2016
Product summary
- Firm
- Fagron, Inc
- Event
- Event 72886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 Bottles
- Official record key
drug-enforcement:D-0654-2016
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Code information: Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination