FDA Drug recall D-0618-2017
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77)
- FDA Drug
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77) 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-0618-2017 |
| 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, 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
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) 3076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Ex…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 |
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-0618-2017%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.