Class II · Moderate risk
Absorica (isotretinoin)
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Balnetar Therapeutic Tar Bath
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
10631-0106-08
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Ranbaxy Inc.
- NDC code
- 10631-106-08
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1405-2012 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Ranbaxy Inc.
All 2012 recalls
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Other wrong potency / content recalls from 2012
All wrong potency / content recalls
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk
Hydrocodone bitartrate and acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class III · Low risk
Clean & Clear advantage
Superpotent (Single Ingredient Drug): salicylic acid
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