🍔 Food 💊 Drugs 🏥 Medical Devices
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637. Class I

Reason: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy 20221201 Terminated
Distributed: BayCare Health System hospitals in FL
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Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01. Class II

Reason: cGMP Deviations

Atlantic Management Resources Ltd. 20221212 Terminated
Distributed: Nationwide and Australia
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ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01. Class II

Reason: cGMP Deviations

Atlantic Management Resources Ltd. 20221212 Terminated
Distributed: Nationwide and Australia
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Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. Class II

Reason: cGMP Deviations

Atlantic Management Resources Ltd. 20221212 Terminated
Distributed: Nationwide and Australia
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Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. Class II

Reason: cGMP Deviations

Atlantic Management Resources Ltd. 20221212 Terminated
Distributed: Nationwide and Australia
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8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1. Class I

Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Exela Pharma Sciences LLC 20221128 Terminated
Distributed: Nationwide within the United States
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8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1. Class I

Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Exela Pharma Sciences LLC 20221128 Terminated
Distributed: Nationwide within the United States
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FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01 Class II

Reason: Underfilled units.

OurPharma LLC 20221129 Terminated
Distributed: MO
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Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00. Class II

Reason: Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.

RemedyRepack Inc. 20221205 Terminated
Distributed: Product was distributed to two different customers in MI.
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0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Class II

Reason: Lack of sterility assurance: Bags have the potential to leak.

B. Braun Medical, Inc. 20221125 Terminated
Distributed: FL, NJ, PA
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