Reported Aug 31, 2016 · Terminated
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201
Is this the product you have?
- Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only
- Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV 26505
- Packaged and Distributed ByUDL Laboratories, Inc., Rockford, IL 61103
- Lot codes and dates
Lot #: a) 3039792Exp 04/143037880Exp 01/143043938Exp 07/14b) 3036811Exp 10/133037514Exp 01/143039975Exp 04/143042583Exp 07/14
- Amount recalled
- a) 9,156 cartons; b) 521,310 cartons
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new produce recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.