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Class II: temporary or reversible health riskTerminated

SCA Pharmaceuticals Calcium GLUCOnate 2 g added to 0 Recall

Calcium GLUCOnate 2 g added to 0

SCA Pharmaceuticals, LLC · Little Rock, AR

Risk level
Class II
Reported by FDA
Nov 8, 2017
Recall ID
D-0067-2018
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled Calcium GLUCOnate 2 g added to 0 starting Oct 19, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0067-2018 on Nov 8, 2017. Reason: Lack Of Assurance Of Sterility. Status: Terminated.

Why it was recalled

Lack Of Assurance Of Sterility.

Product description

Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30

Lot numbers, UPCs & expiration codes

Lot: 20170920@20 BUD: 11/09/2017

Where it was sold

Nationwide in the United States

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-0067-2018
Classification
Class II
Status
Terminated
Recall initiated
Oct 19, 2017
FDA report date
Nov 8, 2017
Quantity
76 bags
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0067-2018, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
78320
Address
8821 Knoedl Ct
Code information
Lot: 20170920@20 BUD: 11/09/2017
Postal code
72205-4600
Report date
Nov 8, 2017
Product type
Drugs
Recall number
D-0067-2018
Classification
Class II
Recalling firm
SCA Pharmaceuticals, LLC
Product quantity
76 bags
Termination date
May 1, 2019
Reason for recall
Lack Of Assurance Of Sterility.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
Distribution pattern
Nationwide in the United States
Recall initiation date
Oct 19, 2017
Initial firm notification
Letter
Center classification date
Nov 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0067-2018, published Nov 8, 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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