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Class I: serious health riskTerminated

Advanced Pharma MAGnesium 2 gm in NS 100 mL Magnesium SULfate Recall

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0

Advanced Pharma Inc. · Houston, TX

Risk level
Class I
Reported by FDA
Jan 31, 2018
Recall ID
D-0575-2018
Check your lot numberHow we source this data

Summary

Advanced Pharma recalled MAGnesium 2 gm in NS 100 mL Magnesium SULfate starting Jan 5, 2018. The FDA classified it as Class I (serious health risk) and published enforcement report D-0575-2018 on Jan 31, 2018. Reason: Subpotent. Status: Terminated.

Why it was recalled

Subpotent

Product description

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

Lot numbers, UPCs & expiration codes

Lot: 12/22/17 1422 108-90710P UD: 3/22/2018

Where it was sold

Texas

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-0575-2018
Classification
Class I
Status
Terminated
Recall initiated
Jan 5, 2018
FDA report date
Jan 31, 2018
Quantity
25 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Advanced Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-0575-2018, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
78889
Address
9265 Kirby Dr
Code information
Lot: 12/22/17 1422 108-90710P UD: 3/22/2018
Postal code
77054-2520
Report date
Jan 31, 2018
Product type
Drugs
Recall number
D-0575-2018
Classification
Class I
Recalling firm
Advanced Pharma Inc.
Product quantity
25 bags
Termination date
Sep 5, 2019
Reason for recall
Subpotent
Voluntary / mandated
Voluntary: Firm initiated
Product description
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
Distribution pattern
Texas
Recall initiation date
Jan 5, 2018
Initial firm notification
Letter
Center classification date
Mar 1, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0575-2018, published Jan 31, 2018. 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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