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Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-cou...

FDA Recall #D-0151-2017 — Class III — November 3, 2016

Recall #D-0151-2017 Date: November 3, 2016 Classification: Class III Status: Terminated

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

Reason for Recall

Failed Impurities/Degradation Specifications: OOS results for known compound.

Recalling Firm

Mylan Pharmaceuticals Inc. — Morgantown, WV

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

51,983 extended release capsules

Distribution

Nationwide

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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