Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 28JN1272, Exp 02/15
- 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:
- Stat Rx USA
- Reason for Recall:
- Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Product Codes/Lot Numbers:
Lot #: 28JN1272, Exp 02/15
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1427-2012
Related Recalls
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."