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Class III: unlikely to cause harmTerminated

Ranbaxy Balnetar Therapeutic Tar Bath Recall

Balnetar Therapeutic Tar Bath, Coal Tar USP 2

Ranbaxy Inc. · Princeton, NJ

Risk level
Class III
Reported by FDA
Jul 11, 2012
Recall ID
D-1405-2012
Check your lot numberHow we source this data

Summary

Ranbaxy recalled Balnetar Therapeutic Tar Bath starting Mar 16, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1405-2012 on Jul 11, 2012. Reason: Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. Status: Terminated.

Why it was recalled

Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.

Product description

Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08

Lot numbers, UPCs & expiration codes

Lot #: RB81031, Exp 01/13

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-1405-2012
Classification
Class III
Status
Terminated
Recall initiated
Mar 16, 2012
FDA report date
Jul 11, 2012
Quantity
2544 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ranbaxy Inc.

Original FDA data

Every field from FDA enforcement report D-1405-2012, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
61934
Address
600 College Rd E Ste 2100
Code information
Lot #: RB81031, Exp 01/13
Postal code
08540-6636
Report date
Jul 11, 2012
Product type
Drugs
Recall number
D-1405-2012
Classification
Class III
Recalling firm
Ranbaxy Inc.
Product quantity
2544 bottles
Termination date
Feb 26, 2013
Reason for recall
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
Distribution pattern
Nationwide
Recall initiation date
Mar 16, 2012
Initial firm notification
Letter
Center classification date
Jul 3, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1405-2012, published Jul 11, 2012. 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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