Reported Apr 5, 2017 · Terminated
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) 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, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
- Lot codes and dates
Lot #: a) 30737793073780Exp 02/183074910Exp 03/183075568Exp 04/1830758893075890Exp 06/1820073392007340Exp 08/1830798813079882Exp 10/18b) 3070839Exp 10/1730737783073779Exp 02/1830755663075567Exp 04/1830758902007225Exp 06/182007340Exp 08/1830798803079881Exp 10/18
- Amount recalled
- 444,201 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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