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, 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.
Lot numbers, UPCs & expiration codes
Lot #s: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277
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-0655-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 11, 2015
- FDA report date
- Feb 17, 2016
- Quantity
- 148 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-0655-2016, 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: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277
- Postal code
- 55120-1118
- Report date
- Feb 17, 2016
- Product type
- Drugs
- Recall number
- D-0655-2016
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- 148 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, 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.
- 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