🍔 Food 💊 Drugs 🏥 Medical Devices
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61 Class III

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Advanced Accelerator Applications USA, Inc. 20230807 Terminated
Distributed: Distributed Nationwide in the USA
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hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case). Class II

Reason: Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.

Colgate Palmolive Company 20230810 Terminated
Distributed: Nationwide in the USSA
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0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 Class III

Reason: Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

B. Braun Medical Inc. 20230802 Terminated
Distributed: United States
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Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86 Class III

Reason: Out of Specification result observed in content uniformity testing

SUN PHARMACEUTICAL INDUSTRIES INC 20230718 Terminated
Distributed: Nationwide in the USA
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Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA Class I

Reason: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Lupin Pharmaceuticals Inc. 20230623 Terminated
Distributed: USA nationwide.
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morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4 Class II

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc 20230717 Terminated
Distributed: Nationwide in the USA
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fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1 Class II

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc 20230717 Terminated
Distributed: Nationwide in the USA
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PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1 Class II

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc 20230717 Terminated
Distributed: Nationwide in the USA
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PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1 Class II

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc 20230717 Terminated
Distributed: Nationwide in the USA
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rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1 Class II

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc 20230717 Terminated
Distributed: Nationwide in the USA
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