Recalls / Class II
Class IID-0655-2016
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.
- Affected lot / code info
- Lot #s: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277
Why it was recalled
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, N/A, Saint Paul, Minnesota 55120-1118
Distribution
- Quantity
- 148 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-11-11
- FDA classified
- 2016-02-05
- Posted by FDA
- 2016-02-17
- Terminated
- 2017-08-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0655-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.