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Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.
Undeclared sulfites.
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Product contains undeclared Oyster Sauce
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Raw California Orange Blossom Honey was recalled due to two random FDA samples tested for unapproved fumagillin (antibiotic drug) residue.
WAWA has initiated a recall of Wawa Iced Tea Less Sugar, Net weight/number of units per package: 12 FL OZ. , Package type: Bottle Units per case: 24, Expiration date: April 29, 2019 (APR/29/19) because of mislabeling. The label reads does not list required phenylketonuria warning and ingredient listing does not list Aspartame.
Failed Impurities/Degradation Specifications
Fungicide carbendazim found in product.
The outer case indicates that the product contains Aspartame; however, the wrap on the individual cans state that the product is Aspartame free.
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.