FDA Drug Low Class III Terminated

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.

Reported: August 27, 2014 Initiated: June 20, 2014 #D-1539-2014

Product Description

Reason for Recall

Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.

Details

Recalling Firm: Mylan Pharmaceuticals Inc.
Units Affected: 9225 Bottles
Distribution: U.S. Nationwide
Location: Morgantown, WV

Frequently Asked Questions

What product was recalled? ▼

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 9225 Bottles.

Why was this product recalled? ▼

Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 27, 2014. Severity: Low. Recall number: D-1539-2014.

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