Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: 3045659, 3048256, Exp 07/14
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Reason for Recall:
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Product Codes/Lot Numbers:

Lot #: 3045659, 3048256, Exp 07/14

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1435-2014

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