Drugs Recalls

Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk

Labeling: Label Mixup; potentially mislabeled

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

Presence of Particulate Matter; stainless steel

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

Crystallization with subpotent out of specification assay results for chlorhexidine.

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.

Crystallization with subpotent out of specification assay results for chlorhexidine.

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Crystallization with subpotent out of specification assay results for chlorhexidine.

Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.