Pantoprazole 40 mg/1

Jubilant Cadista Pharmaceuticals, Inc.

Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.

Aurobindo Pharma USA Inc

Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.

Aidapak Services, LLC

Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.

Methapharm Inc

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

Aidapak Services, LLC

Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014.

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

Pfizer Inc.

Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurity/Degradation Specifications

Jubilant Cadista Pharmaceuticals Inc.

cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.

Sentara Infusion Services

Lack of sterility assurance