Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIHYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIGLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIDEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IICYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IICYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IILEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMagnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IICalcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-10-27FDA-DrugLupin Pharmaceuticals Inc.Class IIImipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- 2021-10-27FDA-DrugDr. Reddy's Laboratories, Inc.Class IIOmeprazole 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
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo 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
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo 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.
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo 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
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo 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.
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugTeva Pharmaceuticals USAClass IIAirDuo 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
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- 2021-10-27FDA-DrugAmerican Health PackagingClass IIGlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
Failed Dissolution Specifications: results were above specification.
- 2021-10-27FDA-DrugPiramal Critical Care, Inc.Class IIRocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
- 2021-10-27FDA-DrugSanitor CorporationClass IICleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
Chemical contamination; presence of benzene
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