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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,003 recalls · newest first

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16

Prescription medicine · SCA Pharmaceuticals, LLC · 5,734 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359

Prescription medicine · SCA Pharmaceuticals, LLC · 368 bags affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 7000408

Prescription medicine · SCA Pharmaceuticals, LLC · 5,948 syringes, expanded 2,102 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 7000403

Prescription medicine · SCA Pharmaceuticals, LLC · 1,023 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Cod

Prescription medicine · SCA Pharmaceuticals, LLC · 10,017 syringes, expanded 2579 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rain

Prescription medicine · SCA Pharmaceuticals, LLC · 613 Cassettes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code

Prescription medicine · SCA Pharmaceuticals, LLC · 3,671 syringes, expanded 1,911 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025

Prescription medicine · SCA Pharmaceuticals, LLC · 9,624 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.

Prescription medicine · SCA Pharmaceuticals, LLC · 400 bags affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009

Prescription medicine · SCA Pharmaceuticals, LLC · 1,122 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 7000403

Prescription medicine · SCA Pharmaceuticals, LLC · 256 cassettes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200

Prescription medicine · SCA Pharmaceuticals, LLC · 1,259 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 70

Prescription medicine · SCA Pharmaceuticals, LLC · 399 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Co

Prescription medicine · SCA Pharmaceuticals, LLC · 1,118 syringes in kits affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar C

Prescription medicine · SCA Pharmaceuticals, LLC · 33,072 syringes; expanded 9,041 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor

Prescription medicine · SCA Pharmaceuticals, LLC · 242 bags affected

Lack of Assurance of Sterility

Food & drug recall · FDANovember 7, 2023Serious

Glenmark Pharmaceuticals Inc., USA — Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 37,200 bottles affected

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Food & drug recall · FDANovember 7, 2023Serious

Glenmark Pharmaceuticals Inc., USA — Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Food & drug recall · FDANovember 6, 2023Highest risk

Bayer Healthcare Pharmaceuticals Inc. — VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only

Prescription medicine · Bayer Healthcare Pharmaceuticals Inc. · 192 bottles affected

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing…

Food & drug recall · FDANovember 6, 2023Labelling issue

Taro Pharmaceuticals Inc. — Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY

Prescription medicine · Taro Pharmaceuticals Inc. · 11,196 bottles affected

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established…