Why it was recalled
Failed Impurities/Degradation Specifications: OOS results for known compound.
Product description
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Lot numbers, UPCs & expiration codes
0378-5220-01 Lot# 3065133; Exp. 03/17 0378-5220-01 Lot# 3066564; Exp. 05/17 0378-5220-05 Lot# 3066564; Exp. 05/17 0378-5220-01 Lot# 3069645; Exp. 08/17 0378-5220-05 Lot# 3069645; Exp. 08/17
Where it was sold
Nationwide
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-0151-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 3, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- 51,983 extended release capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0151-2017, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 75634
- Address
- 781 Chestnut Ridge Rd
- Code information
- 0378-5220-01 Lot# 3065133; Exp. 03/17 0378-5220-01 Lot# 3066564; Exp. 05/17 0378-5220-05 Lot# 3066564; Exp. 05/17 0378-5220-01 Lot# 3069645; Exp. 08/17 0378-5220-05 Lot# 3069645; Exp. 08/17
- Postal code
- 26505-2730
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0151-2017
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 51,983 extended release capsules
- Termination date
- Aug 1, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: OOS results for known compound.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 3, 2016
- Initial firm notification
- Center classification date
- Nov 23, 2016