ASCORBIC/GLUTATHIONE 1.25/1.25% 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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Prescription Drugs
💊 Drugs • 11,927 recalls
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Moisture Limits
CALCIUM GLUCONATE 10% INJ (PF), 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 25/50/50MG/ML MDV, 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
ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), 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
VIT B COMPLEX INJ SOLN (HP), 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
METHYLCOBALAMIN 12.5MG/ML MDV INJ 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
PROGESTERONE 100MG/ML MDV OIL INJECTION, 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
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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/B6 15/50/100 5MG/50MG/ML MDV, 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
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
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
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
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
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
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