Tri-Coast Pharmacy Myers Cocktail #4 recall — FDA D-0274-2017
Lack of Assurance of Sterility
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Lack of Assurance of Sterility: Potential cracks in glass vials
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S.…
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Non Sterility; contaminated with Klebsiella pneumoniae
Failed Dissolution Specifications; 6 month time point
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June…
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Non-Sterility; microbial contamination identified as Bacillus circulans
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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