Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Tolmar, Inc.
- Reason for Recall:
- Subpotent
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-66402-001
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