Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
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Prescription Drugs
💊 Drugs • 12,141 recalls
Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Boehringer Ingelheim Roxane
Class I - Dangerous
Labeling: Missing Label; missing label on blister card
Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
West-Ward Pharmaceutical
Class I - Dangerous
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Class I - Dangerous
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class I - Dangerous
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class I - Dangerous
Presence of foreign substance: One lot of the product may contain black foreign particles
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class I - Dangerous
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Pallimed Solutions
Class I - Dangerous
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class I - Dangerous
Defective container: products are packaged in pouches which may not have been fully sealed