Category
Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIlidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Lack of assurance of sterility:
- 2023-10-11FDA-DrugCentral Admixture Pharmacy Services IncClass IIDo not use Central Admixture fentanyl syringes
Lack of assurance of sterility:
- 2023-10-04FDA-DrugRB Health (US) LLCClass IIIClearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
- 2023-10-04FDA-DrugTolmar, Inc.Class IIIEligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
- 2023-10-04FDA-DrugSofie Co dba SofieClass IIFlorbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
- 2023-09-27FDA-DrugHUMANRACEClass IIHumanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
Subpotent Drug: Product does not contain SPF that is declared on the label.
- 2023-09-27FDA-DrugHUMANRACEClass IIHumanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
Subpotent Drug: Product does not contain SPF that is declared on the label.
- 2023-09-27FDA-DrugNovartis Pharmaceuticals Corp.Class ISANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
- 2023-09-27FDA-DrugVi-Jon, LLCClass IIIKroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
Incorrect/Undeclared Excipients.
- 2023-09-27FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIICequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
Subpotent: Out of Specification result observed for low assay
- 2023-09-27FDA-DrugAurobindo Pharma USA Inc.Class IIRasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Failed dissolution specifications - results obtained were below spec average.
- 2023-09-27FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shi
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IIoctiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IIMAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
Lack of Assurance of Sterility
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.
Lack of Assurance of Sterility
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