Reported Apr 5, 2017 · Terminated
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC…
Mylan Pharmaceuticals Inc.
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 Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
- Lot codes and dates
Lot #: a) 3073776Exp 01/1830737773074909Exp 02/1830755643075565Exp 03/182007338Exp 08/18b) 3070838Exp 10/173073775Exp 01/1830749083074909Exp 02/183075564Exp 03/1820072243075887Exp 06/1820073372007338Exp 08/18
- Amount recalled
- 299,112 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
This product could cause temporary or reversible health problems — stop using it.
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