Recalls / Class I
Class ID-1610-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
- Brand name
- Dianeal Low Calcium With Dextrose
- Generic name
- Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
- Active ingredients
- Calcium Chloride, Dextrose Monohydrate, Magnesium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intraperitoneal
- NDCs
- 0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424 +5 more
- FDA application
- NDA017512
- Affected lot / code info
- Lot #: C940700, C940841, Exp 05/16
Why it was recalled
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Vantive US Healthcare LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 50,530 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-07
- FDA classified
- 2014-09-26
- Posted by FDA
- 2014-10-08
- Terminated
- 2017-04-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1610-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.