Recalls / Class III
Class IIID-162-2013
Product
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
- Affected lot / code info
- Lot #: RB93911, Exp 07/14
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.
Recalling firm
- Firm
- Ranbaxy Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 2100, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 4,016 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-12-27
- FDA classified
- 2013-02-12
- Posted by FDA
- 2013-02-20
- Terminated
- 2014-04-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-162-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.