NDC 0941-0427 – DIANEAL PD-2 with Dextrose
Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538 mg/100mL; Sodium Lactate 448 mg/100mL; Calcium Chloride 25.7 mg/100mL; Magnesium Chloride 5.08 mg/100mL · Injection, Solution · Intraperitoneal
Product NDC0941-0427
Product details
- Brand name
- DIANEAL PD-2 with Dextrose
- Generic name
- Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
- Labeler
- Vantive US Healthcare LLC
- Dosage form
- Injection, Solution
- Route
- Intraperitoneal
- Marketing category
- NDA · NDA020163
- Marketed since
- December 4, 1992
- Listing expires
- December 31, 2027
- Pharmacologic class
- Blood Coagulation Factor; Calculi Dissolution Agent; Osmotic Laxative; Osmotic Laxative; Osmotic Laxative; Phosphate Binder
Active ingredients
- Dextrose Monohydrate 2.5 g/100mL
- Sodium Chloride 538 mg/100mL
- Sodium Lactate 448 mg/100mL
- Calcium Chloride 25.7 mg/100mL
- Magnesium Chloride 5.08 mg/100mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0941-0427-52 | 2000 mL in 1 BAG (0941-0427-52) | Dec 4, 1992 |
| 0941-0427-53 | 2500 mL in 1 BAG (0941-0427-53) | Dec 4, 1992 |
Recalls mentioning this NDC
- D-0587-2024 Jul 17, 2024 · Class II
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. - D-1141-2023 Sep 6, 2023 · Class II
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. - D-1140-2023 Sep 6, 2023 · Class II
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. - D-0543-2023 May 3, 2023 · Class II
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. - D-0542-2023 May 3, 2023 · Class II
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. - D-0351-2019 Jan 16, 2019 · Class II
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. - D-1610-2014 Oct 8, 2014 · Class I
Presence of Particulate Matter: particulate matter was found during the manufacturing process. - D-1276-2014 May 7, 2014 · Class I
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. - D-831-2013 Aug 7, 2013 · Class II
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Other DIANEAL PD-2 with Dextrose products
- 0941-0411 Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538 mg/100mL;… · Injection, Solution · Vantive US Healthcare LLC
- 0941-0413 Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538 mg/100mL;… · Injection, Solution · Vantive US Healthcare LLC
- 0941-0415 Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538 mg/100mL;… · Injection, Solution · Vantive US Healthcare LLC
- 0941-0426 Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538 mg/100mL;… · Injection, Solution · Vantive US Healthcare LLC
- 0941-0429 Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538 mg/100mL;… · Injection, Solution · Vantive US Healthcare LLC
- 0941-0698 Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538 mg/100mL;… · Injection, Solution · Vantive US Healthcare LLC