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
Reported: April 5, 2017 Initiated: March 21, 2017 #D-0622-2017
Product Description
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.
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 1,527 cartons
- Distribution
- Nationwide in the USA
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 1,527 cartons.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2017. Severity: Moderate. Recall number: D-0622-2017.
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