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Class I: serious health riskTerminated

Specialty Compounding CALCIUM GLUCONATE 2 gm Recall

CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0

Specialty Compounding, LLC · Cedar Park, TX

Risk level
Class I
Reported by FDA
Nov 5, 2014
Recall ID
D-0230-2015
Check your lot numberHow we source this data

Summary

Specialty Compounding recalled CALCIUM GLUCONATE 2 gm starting Aug 9, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-0230-2015 on Nov 5, 2014. Reason: Non Sterility: Microbial contamination. Status: Terminated.

Why it was recalled

Non Sterility: Microbial contamination

Product description

CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

Lot numbers, UPCs & expiration codes

Lot #: 07092013M16; Exp 09/13

Where it was sold

Nationwide

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-0230-2015
Classification
Class I
Status
Terminated
Recall initiated
Aug 9, 2013
FDA report date
Nov 5, 2014
Quantity
Undetermined
Recall type
Voluntary: Firm initiated
Recalling firm
Specialty Compounding, LLC

Original FDA data

Every field from FDA enforcement report D-0230-2015, exactly as published.

Show all FDA fields
City
Cedar Park
State
TX
Status
Terminated
Country
United States
Event ID
65953
Address
211 South Bell (Hwy 183 N)
Code information
Lot #: 07092013M16; Exp 09/13
Postal code
78613
Report date
Nov 5, 2014
Product type
Drugs
Recall number
D-0230-2015
Classification
Class I
Recalling firm
Specialty Compounding, LLC
Product quantity
Undetermined
Termination date
Sep 22, 2016
Reason for recall
Non Sterility: Microbial contamination
Voluntary / mandated
Voluntary: Firm initiated
Product description
CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Distribution pattern
Nationwide
Recall initiation date
Aug 9, 2013
Initial firm notification
Press Release
Center classification date
Oct 30, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0230-2015, published Nov 5, 2014. 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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