Recalls / Class II
Class IID-0654-2016
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.
- Affected lot / code info
- Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406
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
- 44 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-0654-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.