Reported Aug 31, 2016 · Terminated
Amlodipine Besylate Tablets, USP, 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?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | 100-count (10 x |
| 2 | unit dose blisters per carton, NDC 51079-451-20 |
| 3 | 300-count (10 x |
| 4 | unit dose blisters per carton, NDC 51079-451-56 |
| 5 | 25-count (25 x |
| 6 | Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and |
| 7 | 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 3038339, Exp 02/14; 3043618, Exp 06/14 2 3041862, Exp 05/14; 3044258, Exp 06/14 3 2120031, Exp 01/14; 2120067, Exp 06/14 4 3035787, 3035834, 3035835, Exp 10/13; 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, Exp 01/14; 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, Exp 02/14; 3040567, 3040977, Exp 04/14; 3041253, 3041800, 3041801, Exp 05/14; 3042446, 3042624, 3043015, Exp 06/14; 3043401, 3043466, Exp 08/14; 3044590, Exp 09/14; 3044591, Exp 10/14; 3045063, 3045064, Exp 11/14 - Amount recalled
- a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 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.
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