FDA Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
by TMC Acquisitions LLC dba Tailor Made Compounding
- Reason
- Lack of Assurance of Sterility
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
by TMC Acquisitions LLC dba Tailor Made Compounding
- Reason
- Lack of Assurance of Sterility
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
by Baxter Healthcare Corporation
- Reason
- Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Subpotent: Out of Specification for Assay Test at the 3-month time point.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
by Imprimis NJOF, LLC
- Reason
- Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- 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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