Recalls / Class I
Class ID-1276-2014
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 PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
- 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 number: C903799, Exp 05/15
Why it was recalled
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Vantive US Healthcare LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 27,169 containers
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-02-11
- FDA classified
- 2014-04-25
- Posted by FDA
- 2014-05-07
- Terminated
- 2015-07-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1276-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.