Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Recalls
FDA
Showing 21-22 of 22 recalls
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.