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Methylcobalamin Injection (South Coast) – Sterility Concern (2013)

Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.

Class IIModerate

FDAAug 23, 2013CA, IN• South Coast Specialty Compounding, Inc.

Children's Ibuprofen (Parallon) – Color Discoloration (2013)

CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.

Class IIModerate

FDAAug 23, 2013GA, KY, TN• Central Shared Services dba Parallon

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Methylcobalamin Injection (South Coast) – Sterility Concern (2013)

Children's Ibuprofen (Parallon) – Color Discoloration (2013)

Glutathione Injectable (Creative Compounds) – Contamination Risk (2013)

Epinephrine Solution (JCB Labs) – Sterility Concern (2013)

Progesterone Injection (Walgreens) – Sterility Concern (2013)

Dexpanthenol Vial (Wellness Pharmacy) – Sterility Concern (2013)

Sodium Citrate Solution (JCB Labs) – Sterility Concern (2013)

Testosterone Cypionate (Medaus) – Sterility Concern (2013)

Taurine Solution (Medaus) – Sterility Concern (2013)

Magnesium Chloride (Medaus) – Microbial Contamination (2013)

Testosterone Cypionate (South Coast) – Sterility Concern (2013)

Ascorbate Solution (Medaus) – Sterility Concern (2013)

Fish Hot Dogs (Schafer Fisheries) – HACCP records issue (2013)

Twin Fin Salami (Schafer Fisheries) – HACCP records issue (2013)

Gefilte Fish (Schafer Fisheries) – HACCP records issue (2013)

Tropical Fruit & Nut Blend (Ann's House) – undeclared color (2013)

Ducal Prepared Sauce Queso (Kern's) – pH Level Concern (2013)

SuperBudin (Lucy's Kitchen) – Undeclared Wheat, Soy (2013)

Human Breast Milk (Mothers Milk Bank) – Hepatitis B Risk (2013)

SuperPan Tu Pan Natural (Lucy's Kitchen) – Undeclared Wheat (2013)