Why it was recalled
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Product description
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Lot numbers, UPCs & expiration codes
Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.
Where it was sold
Nationwide and Puerto Rico
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-086-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 21, 2012
- FDA report date
- Dec 12, 2012
- Quantity
- 39,982 Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-086-2013, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 63685
- Address
- 3 Skyline Dr
- Code information
- Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.
- Postal code
- 10532-2174
- Report date
- Dec 12, 2012
- Product type
- Drugs
- Recall number
- D-086-2013
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 39,982 Tubes
- Termination date
- Apr 11, 2017
- Reason for recall
- Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 4, 2012