March 2017 FDA Recall Atorvastatin Calcium by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) (D-0622-2017 - Microbial Contamination of Non-Sterile Products)
This Class II drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on March 21, 2017 for the product Atorvastatin Calcium. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0622-2017
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
03-21-2017
04-05-2017
1,527 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
03-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : 3084288, Exp. 07/18
