Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: 3045659, 3048256, Exp 07/14
Where it was sold
Nationwide, Puerto Rico, and Guam.
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-1435-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 3, 2014
- FDA report date
- Jul 23, 2014
- Quantity
- 1,184 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-1435-2014, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68787
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3045659, 3048256, Exp 07/14
- Postal code
- 61103-1201
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1435-2014
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 1,184 cartons
- Termination date
- Jul 26, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide, Puerto Rico, and Guam.
- Recall initiation date
- Jul 3, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2014