Status
Terminated
Drug Enforcement D-66402-001
Subpotent
Classification
Class III
Report Date
October 30, 2013
Termination Date
April 10, 2014
Product Information
- Product description
- Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
- Product quantity
- 391,055 bottles
- Reason for recall
- Subpotent
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Tolmar, Inc.
- Address
-
701 Centre Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66402-001
- Event ID
- 66402
- Recall initiation date
- September 23, 2013
- Center classification date
- October 18, 2013
- Code info
- Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14
- More code info
- —