SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 515
Summary
The FDA issued a Class I for SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC by Fagron, Inc. Reason: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli..
Details
Source
Drug Recall
External ID
D-0856-2022
Action Date
2022-05-18
Status
Completed
Category
drug
Product Description
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Lot/Code Info: Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
Quantity Affected: a) 559 bottles and b) 243 bottles
Reason for Recall
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Distribution
Nationwide USA and Puerto Rico, Canada, Columbia, France
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-04
Company
Saint Paul, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fagron, Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fagron, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fagron, Inc have FDA actions?
Fagron, Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0856-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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