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

FDA recall notice · announced April 5, 2017 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 3084288, Exp. 07/18
Quantity: 1,527 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0622-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.