Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Product description
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Lot numbers, UPCs & expiration codes
Batch code # 3093163, expiration date 04/2019
Where it was sold
Distributed Nationwide in the US
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-1186-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 7, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 11,799 bottles of 100
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1186-2018, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 80782
- Address
- 781 Chestnut Ridge Rd
- Code information
- Batch code # 3093163, expiration date 04/2019
- Postal code
- 26505-2730
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1186-2018
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 11,799 bottles of 100
- Termination date
- Aug 14, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Aug 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 10, 2018