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Class II: temporary or reversible health riskTerminated

Bella Pharmaceuticals Magnesium Chloride 200mg Recall

Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W

Bella Pharmaceuticals, Inc. · Chicago, IL

Risk level
Class II
Reported by FDA
Sep 20, 2017
Recall ID
D-1153-2017
Check your lot numberHow we source this data

Summary

Bella Pharmaceuticals recalled Magnesium Chloride 200mg starting Aug 15, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1153-2017 on Sep 20, 2017. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility.

Product description

Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Lot numbers, UPCs & expiration codes

Lot #: BPMC08517, Exp. 2/5/18

Where it was sold

Nationwide within 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-1153-2017
Classification
Class II
Status
Terminated
Recall initiated
Aug 15, 2017
FDA report date
Sep 20, 2017
Quantity
5 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Bella Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1153-2017, exactly as published.

Show all FDA fields
City
Chicago
State
IL
Status
Terminated
Country
United States
Event ID
77959
Address
3101 W Devon Ave
Code information
Lot #: BPMC08517, Exp. 2/5/18
Postal code
60659-1407
Report date
Sep 20, 2017
Product type
Drugs
Recall number
D-1153-2017
Classification
Class II
Recalling firm
Bella Pharmaceuticals, Inc.
Product quantity
5 vials
Termination date
Apr 23, 2018
Reason for recall
Lack of Assurance of Sterility.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Distribution pattern
Nationwide within USA
Recall initiation date
Aug 15, 2017
Initial firm notification
Telephone
Center classification date
Sep 12, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1153-2017, published Sep 20, 2017. 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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