Reported Aug 31, 2016 · Terminated
Amlodipine Besylate Tablets, USP, 10 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?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 100-count (10 x |
| 2 | unit dose blisters per carton, NDC 51079-452-20 |
| 3 | 300-count (10 x |
| 4 | unit dose blisters per carton, NDC 51079-452-56; and |
| 5 | 25-count (25 x |
| 6 | Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103. |
- Lot codes and dates
Lot #: a) 30397953042896Exp 04/14b) 30397933042892Exp 04/14c) 2120054Exp 02/142120090Exp 05/14
- Amount recalled
- a) 11,064 cartons; b) 2,052 cartons; c) 5,567 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.