Mallinckrodt recalls
FDA enforcement reports naming Mallinckrodt Inc as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Jun 17, 2015
- Jun 17, 2015MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)Drug · Mallinckrodt, Inc.Labeling: incorrect or missing lot number and/or expiration dateClass II
- Oct 3, 2012Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2Drug · Mallinckrodt IncLabeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)Class III
- Aug 8, 2012Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7Drug · Mallinckrodt Inc.Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.Class III
- Aug 8, 2012Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7Drug · Mallinckrodt Inc.CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.Class II