Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Product description
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Lot numbers, UPCs & expiration codes
Batch 3096049
Where it was sold
Nationwide USA
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-1112-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 14, 2018
- FDA report date
- Aug 29, 2018
- Quantity
- 408 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-1112-2018, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80802
- Address
- 1718 Northrock Ct
- Code information
- Batch 3096049
- Postal code
- 61103-1201
- Report date
- Aug 29, 2018
- Product type
- Drugs
- Recall number
- D-1112-2018
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 408 cartons
- Termination date
- Jun 26, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Aug 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2018