Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Product description
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Lot numbers, UPCs & expiration codes
Lot #: 3090167, Exp. October 2019
Where it was sold
Throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0506-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 13, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 8,159 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0506-2019, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 82086
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 3090167, Exp. October 2019
- Postal code
- 26505-2730
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0506-2019
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 8,159 bottles
- Termination date
- Sep 12, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
- Distribution pattern
- Throughout the United States
- Recall initiation date
- Feb 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2019