FDA Drug recall D-0619-2017
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07)
- FDA Drug
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07) by Mylan Pharmaceuticals, citing microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0619-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-20 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
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
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Identifiers
| ndc | 0378-3950-77 |
|---|---|
| ndc | 0378-3950-05 |
| ndc | 0378-3950-09 |
| ndc | 0378-3950-07 |
| ndc | 0378-3951-77 |
| ndc | 0378-3951-05 |
| ndc | 0378-3951-09 |
| ndc | 0378-3951-07 |
| ndc | 0378-3952-77 |
| ndc | 0378-3952-05 |
| ndc | 0378-3952-09 |
| ndc | 0378-3952-07 |
| ndc | 0378-3953-77 |
| ndc | 0378-3953-05 |
| ndc | 0378-3953-09 |
| ndc | 0378-3953-07 |
| code_info | Lot #: a) 3073776, Exp 01/18; 3073777, 3074909, Exp 02/18; 3075564, 3075565, Exp 03/18; 2007338, Exp 08/18; b) 3070838,…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.