Baxter Healthcare Corp.
Product Description:5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Status:Ongoing
City:Deerfield
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:US, Puerto Rico, and Bermuda
Classification:Class I
Product Quantity:402,284 bags
Reason For Recall:Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall Initiation Date:20150324
Report Date:20150715

Protonix Delayed-release

Protonix Delayed-release

Protonix Delayed-release Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:

1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)

PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

1.2 Maintenance of Healing of Erosive Esophagitis

PROTONIX is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

History

There is currently no drug history available for this drug.

Other Information

The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:

Chemical Structure

Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.

The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

PROTONIX (pantoprazole sodium) is supplied as a for delayed-release oral suspension, available in one strength (40 mg), and as a delayed-release tablet, available in two strengths (20 mg and 40 mg).

Each PROTONIX (pantoprazole sodium) Delayed-Release Tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.

PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension, 40 mg, contains the active ingredient pantoprazole sodium sesquihydrate in the form of enteric‑coated granules in unit dose packets. Each unit dose packet contains enteric-coated granules containing 45.1 mg pantoprazole sodium sesquihydrate (equivalent to 40 mg of pantoprazole) with the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.

Protonix Delayed-release Manufacturers


  • Stat Rx Usa Llc
    Protonix Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Stat Rx Usa Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Protonix Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Physicians Total Care, Inc.
    Protonix Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Physicians Total Care, Inc.]
  • Cardinal Health
    Protonix Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release Protonix Delayed-release (Pantoprazole Sodium) Granule, Delayed Release [Cardinal Health]
  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Protonix Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release Protonix Delayed-release (Pantoprazole Sodium) Granule, Delayed Release [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]

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