Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
SyrSpend SF
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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 NDC
51552-1079-05
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| SyrSpend SF NDC 51552-1079 |
STARCH, CORN 1 g/g; SUCRALOSE 1 g/g; ANHYDROUS CITRIC ACID 1 g/g; SODIUM BENZOATE 1 g/g | Suspension | Fagron Inc | BULK INGREDIENT |
- Recalling firm
- Fagron, Inc
- NDC code
- 51552-1079-5
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0654-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Fagron, Inc
All 2015 recalls
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Other microbial contamination recalls from 2015
All microbial contamination recalls
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
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