Reported Apr 5, 2017 · Terminated
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 90-count bottles (NDC 0378-3950-77) |
| 2 | 90-count bottles (NDC 0378-3950-09) |
| 3 | 500-count bottles (NDC 0378-3950-05) |
| 4 | 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 3076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Exp 09/18; 3084692, Exp 01/18 2 3073773, Exp 01/18; 2007445, Exp 09/18 3 3076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18 4 3070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18 - Amount recalled
- 1,233,107 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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