Drug product
SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.
D-0655-2016
Product summary
- Firm
- Fagron, Inc
- Event
- Event 72886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 Bottles
- Official record key
drug-enforcement:D-0655-2016
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: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination