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Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Presence of Particulate Matter
CGMP Deviations: Shipment of product not approved for release.
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
The product contains undeclared wheat.
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Best Maid Cookie Company is voluntarily recalling Sienna Bakery¿ Oatmeal Walnut Raisin and Sienna Bakery¿ White Chocolate Macadamia Nut cookies due to a potential mis-pack, resulting in an undeclared allergen. Oatmeal Walnut Raisin cookies may have been inadvertently packed in White Chocolate Macadamia Nut retail boxes. Oatmeal Walnut Raisin cookies contain walnuts which are NOT declared on the W
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Product ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
GMP deviation; Sr-82 levels exceeded alert limit specification
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Impurities/Degradation Products: exceeded specification at 3 month stability testing