Diltiazem HCl Extended-release Capsules recall: Impurity Out of Spec
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…
Why was Diltiazem HCl Extended-release Capsules recalled?
Failed Impurities/Degradation Specifications: OOS results for known compound.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 51,983 extended release capsules
- Distribution
- Nationwide
- Recall date
- November 30, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)