FDA Recall
Terminated
Historical recordClass II
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility.
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications.
- Published
- February 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.
by Medique Products
- Reason
- CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
by VistaPharm, Inc.
- Reason
- Failed Stability Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
by MYLAN PHARMACEUTICALS INC
- Reason
- Labeling: Missing Label: label missing from some Semglee prefilled pens.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
by Medique Products
- Reason
- CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6
by Medique Products
- Reason
- CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent drug
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
by Mayne Pharma Inc
- Reason
- CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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