FDA Drug recall D-0622-2017
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc…
- 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*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc… by Mylan Institutional D B A Udl Laboratories, 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-0622-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-21 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
Product
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Reason
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Identifiers
| ndc | 51079-208-01 |
|---|---|
| ndc | 51079-208-20 |
| ndc | 51079-209-01 |
| ndc | 51079-209-20 |
| ndc | 51079-210-01 |
| ndc | 51079-210-20 |
| ndc | 51079-211-01 |
| ndc | 51079-211-03 |
| code_info | Lot #: 3084288, Exp. 07/18 |
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-0622-2017%22
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