D-0619-2017 Class II Terminated
FDA drug recall D-0619-2017 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: 299,112 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
- 299,112 bottles
Product description
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.
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) 3073776, Exp 01/18; 3073777, 3074909, Exp 02/18; 3075564, 3075565, Exp 03/18; 2007338, Exp 08/18; b) 3070838, Exp 10/17; 3073775, Exp 01/18; 3074908, 3074909, Exp 02/18; 3075564, Exp 03/18; 2007224, 3075887, Exp 06/18; 2007337, 2007338, Exp 08/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0619-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026