Why it was recalled
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Product description
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
Lot numbers, UPCs & expiration codes
Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13
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-163-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 27, 2012
- FDA report date
- Feb 20, 2013
- Quantity
- 6,535 tubes and bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ranbaxy Inc.
Original FDA data
Every field from FDA enforcement report D-163-2013, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64286
- Address
- 600 College Rd E Ste 2100
- Code information
- Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13
- Postal code
- 08540-6636
- Report date
- Feb 20, 2013
- Product type
- Drugs
- Recall number
- D-163-2013
- Classification
- Class III
- Recalling firm
- Ranbaxy Inc.
- Product quantity
- 6,535 tubes and bottles
- Termination date
- Apr 9, 2014
- Reason for recall
- Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 27, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 12, 2013