Atorvastatin Calcium Tablets — Class II drug recall D-0622-2017
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2017-04-05, distributed nationwide. Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of obj
| Recall number | D-0622-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2017-03-21 |
| Classified | 2017-03-28 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2019-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,527 cartons |
| Reason classes | microbial contamination, sterility |
| NDC | 51079-0208, 51079-0208-01, 51079-0208-20, 51079-0209, 51079-0209-01, 51079-0209-20, 51079-0210, 51079-0210-01, 51079-0210-20, 51079-0211, 51079-0211-01, 51079-0211-03 |
| Lot numbers | 07/18, 3084288 |
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 for recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0622-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.