Phentermine HCL Capsules, USP 15 mg recall — FDA D-1083-2017
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
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…
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…
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.
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.
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.
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.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Presence of Particulate Matter: Silicone oil
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