Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Failed Stability Specification; out of specification result for particle size distribution during stability testing
Distributed: NationwideReason: Subpotent Drug.
Distributed: U.S. NationwideReason: Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Distributed: PAReason: Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Distributed: Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.