D-0618-2017 Class II Terminated
FDA drug recall D-0618-2017 was initiated by Mylan Pharmaceuticals Inc. on Mar 20, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. The recall status is terminated (terminated Jan 26, 2018). Affected quantity: 1,233,107 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 5, 2017
- Initiation Date
- Mar 20, 2017
- Termination Date
- Jan 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,233,107 bottles
Product description
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason for recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Distribution pattern
Nationwide in the USA and Puerto Rico
Code information
Lot #: a) 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; b) 3073773, Exp 01/18; 2007445, Exp 09/18; c) 3076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18; d) 3070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0618-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026