Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IISUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIRocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIMorphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IISUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IISodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIRocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIneostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IImorphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIIMorphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IILidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IILidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIlabetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIKetamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIHYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIHYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIGlycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIEsmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIBuffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIAtropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugAscend Laboratories LLCClass IICephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
- 2021-01-13FDA-DrugMerck Sharp & DohmeClass IIZerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
- 2021-01-06FDA-DrugWishgarden Herbs, IncorporatedClass IGoldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
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