Recalls / Class II
Class IID-0622-2017
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
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 51079-208, 51079-209, 51079-210, 51079-211
- FDA application
- ANDA091226
- Affected lot / code info
- Lot #: 3084288, Exp. 07/18
Why it was recalled
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Manufacturer
- Mylan Institutional Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,527 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-03-21
- FDA classified
- 2017-03-28
- Posted by FDA
- 2017-04-05
- Terminated
- 2019-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0622-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.