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.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0654-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 11, 2015
- FDA report date
- Feb 17, 2016
- Quantity
- 44 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-0654-2016, exactly as published.
Show all FDA fields
- City
- Saint Paul
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 72886
- Address
- 2400 Pilot Knob Rd
- Code information
- Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406
- Postal code
- 55120-1118
- Report date
- Feb 17, 2016
- Product type
- Drugs
- Recall number
- D-0654-2016
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- 44 Bottles
- Termination date
- Aug 22, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 11, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 5, 2016