Class I · High risk Terminated
NP Thyroid 90
Reason Superpotent Drug.
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Class I · High risk Terminated
NP Thyroid 60
Reason Superpotent Drug.
Class I · High risk Terminated
NP Thyroid 30
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class III · Low risk Terminated
Zilretta
Reason Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk Ongoing
Maximum Strength Lidocaine Cold & Hot Patch
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
Mencaine
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
LidoPro
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
LidoPatch
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Terminated
EcoLips Sport Lip Balm
Reason Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Class II · Moderate risk Terminated
Estriol USP Micronized 5 G
Reason Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk Terminated
Doxycycline Hyclate tablets USP
Reason Failed dissolution specifications
Class III · Low risk Terminated
Gabapentin Tablets USP
Reason Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III · Low risk Terminated
Ethacrynic Acid Tablets USP
Reason Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets USP
Reason Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Class II · Moderate risk Terminated
Sterile Curcumin 50mg/mL
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Curcumin
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Carbamazepine Tablets
Reason Failed Dissolution Specifications