Status
Terminated
Drug Enforcement D-162-2013
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Classification
Class III
Report Date
February 20, 2013
Termination Date
April 9, 2014
Product Information
- Product description
- Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
- Product quantity
- 4,016 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Ranbaxy Inc.
- Address
-
600 College Rd E Ste 2100
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-162-2013
- Event ID
- 64286
- Recall initiation date
- December 27, 2012
- Center classification date
- February 12, 2013
- Code info
- Lot #: RB93911, Exp 07/14
- More code info
- —