Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
- 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:
- Sandoz Incorporated
- Reason for Recall:
- Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Product Codes/Lot Numbers:
Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-383-2014
Related Recalls
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
Sandoz Incorporated
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Cross Contamination With Other Product: Imipramine
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Sandoz Incorporated
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)