Imipenem/ cilastatin various strength in normal saline bags Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Ceftazidime various strength in normal saline bags Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Cefoxitin various strength in normal saline bags Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Cefepime various strengths in normal saline Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Aztreonam 1 gram in normal saline Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Amikacin various strength in normal saline bags Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Liposomal Amphotericin B 130 mg in dextrose bags Class II

Reason: Lack of sterility assurance.

Walgreens Infusion Services 20141226 Terminated
Distributed: Texas, Florida, Virginia, Georgia, Louisiana, Mississippi
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059 Class II

Reason: Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".

SCA Pharmaceuticals 20150102 Terminated
Distributed: Louisiana
Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. Class II

Reason: Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Actavis Elizabeth LLC 20141215 Terminated
Distributed: Puerto Rico
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11 Class II

Reason: Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Actavis Elizabeth LLC 20141215 Terminated
Distributed: Puerto Rico
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