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Class II: temporary or reversible health riskTerminated

Boehringer Ingelheim Roxane Calcitriol Oral Solution 1 mcg/mL Recall

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc

Boehringer Ingelheim Roxane Inc · Columbus, OH

Risk level
Class II
Reported by FDA
Jul 16, 2014
Recall ID
D-1427-2014
Check your lot numberHow we source this data

Summary

Boehringer Ingelheim Roxane recalled Calcitriol Oral Solution 1 mcg/mL starting May 1, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1427-2014 on Jul 16, 2014. Reason: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point. Status: Terminated.

Why it was recalled

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Product description

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

Lot numbers, UPCs & expiration codes

Lot # 360122A, EXP Date: MAY 2015

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-1427-2014
Classification
Class II
Status
Terminated
Recall initiated
May 1, 2014
FDA report date
Jul 16, 2014
Quantity
5364 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Boehringer Ingelheim Roxane Inc

Original FDA data

Every field from FDA enforcement report D-1427-2014, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
68389
Address
1809 Wilson Rd
Code information
Lot # 360122A, EXP Date: MAY 2015
Postal code
43228-9579
Report date
Jul 16, 2014
Product type
Drugs
Recall number
D-1427-2014
Classification
Class II
Recalling firm
Boehringer Ingelheim Roxane Inc
Product quantity
5364 bottles
Termination date
Apr 1, 2015
Reason for recall
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Voluntary / mandated
Voluntary: Firm initiated
Product description
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Distribution pattern
Nationwide
Recall initiation date
May 1, 2014
Center classification date
Jul 9, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1427-2014, published Jul 16, 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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