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Class II: temporary or reversible health riskCompleted

Methapharm Pantoprazole sodium for Injection 40 mg*/vial Recall

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intraveno…

Methapharm Inc · Coral Springs, FL

Risk level
Class II
Reported by FDA
May 3, 2023
Recall ID
D-0540-2023
Check your lot numberHow we source this data

Summary

Methapharm recalled Pantoprazole sodium for Injection 40 mg*/vial starting Apr 7, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0540-2023 on May 3, 2023. Reason: CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. Status: Completed.

Why it was recalled

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

Product description

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).

Lot numbers, UPCs & expiration codes

Lots: 220801; 220802; 220803 Exp. July 2024

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0540-2023
Classification
Class II
Status
Completed
Recall initiated
Apr 7, 2023
FDA report date
May 3, 2023
Quantity
5377 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Methapharm Inc

Original FDA data

Every field from FDA enforcement report D-0540-2023, exactly as published.

Show all FDA fields
City
Coral Springs
State
FL
Status
Completed
Country
United States
Event ID
92113
Address
11772 W Sample Rd Ste 101
Code information
Lots: 220801; 220802; 220803 Exp. July 2024
Postal code
33065-3166
Report date
May 3, 2023
Product type
Drugs
Recall number
D-0540-2023
Classification
Class II
Recalling firm
Methapharm Inc
Product quantity
5377 cartons
Reason for recall
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
Distribution pattern
Nationwide in the USA
Recall initiation date
Apr 7, 2023
Initial firm notification
Letter
Center classification date
Apr 21, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0540-2023, published May 3, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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