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Leuprolide Micro Lupron Kit (Perry Drug) – Sterility Concern (2014)

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Class IIModerate

FDANov 7, 2014KS, MO• Perry Drug Inc.

HCG Injection (Perry Drug) – sterility concerns (2014)

Class IIModerate

FDA

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Leuprolide Micro Lupron Kit (Perry Drug) – Sterility Concern (2014)

HCG Injection (Perry Drug) – sterility concerns (2014)

Sodium Tetradecyl Injection (Perry Drug) – Sterility Concern (2014)

Vancomycin Injection (Hospira) – product mislabeling (2014)

Forever Beautiful Bee Pollen (REFA Enterprises) – unapproved ingredients (2014)

Forever Beautiful Infinity (REFA Enterprises) – unapproved ingredients (2014)

Heparin Sodium Injection (Baxter Healthcare) – low potency (2014)

Chlorhexidine Surgical Scrub (CareFusion) – concentration issue (2014)

Meropenem Injection (Hospira) – container defect (2014)

Mercaptopurine Tablets (Prometheus Labs) – dissolution failure (2014)

BiliVen Capsules (Premier Research Labs) – Undeclared Wheat (2014)

Quantum Gallbladder Support (Premier Research Labs) – Undeclared Wheat (2014)

Carbamazepine Tablets (Taro Pharmaceuticals) – unauthorized sale (2014)

Z-COTE Zinc Oxide (Nanophase Technologies) – manufacturing error (2014)

Obagi Nu-Derm Clear (Obagi Medical) – Labeling Mix-Up (2014)

Gabapentin Capsules (Aurobindo Pharma) – Empty Capsules (2014)

Candesartan Cilexetil Tablets (Apotex) – Impurity Specification Failure (2014)

Candesartan Cilexetil Tablets (Apotex) – Impurity Specifications (2014)

Candesartan Cilexetil Tablets (Apotex) – Impurity Specification Failure (2014)

Cyproheptadine HCl Syrup (Pharmaceutical Associates) – Impurity Issue (2014)