ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class I - Dangerous
Chemical contamination; presence of benzene
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
Chemical contamination; presence of benzene
Class I - Dangerous
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class I - Dangerous
Failed Dissolution Specifications: results were above specification.
Class I - Dangerous
Chemical contamination; presence of benzene
Class I - Dangerous
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class I - Dangerous
Chemical contamination; presence of benzene
Class I - Dangerous
cGMP Deviations
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class I - Dangerous
cGMP Deviations
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Dr. Reddy's Laboratories
Class I - Dangerous
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class I - Dangerous
Chemical contamination; presence of benzene
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol