FDAFDA · Food and drugs·Recall number D-0151-2017
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
Published November 30, 2016 · Recall initiated: November 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: OOS results for known compound.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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