Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-12-03FDA-DrugPerry Drug Inc.Class II2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IIHCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IIHCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IIHCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IITri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IIHCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IITestosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IIPhenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IILeuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IITri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IIMethyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugPerry Drug Inc.Class IITestosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-12-03FDA-DrugActavis Laboratories, FL, Inc.Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
- 2014-12-03FDA-DrugZydus Pharmaceuticals USA IncClass IIIAmlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
- 2014-12-03FDA-DrugBaxter Healthcare Corp.Class IIPotassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
- 2014-11-26FDA-DrugSpectrum Laboratory ProductsClass IITetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
- 2014-11-26FDA-DrugHospira Inc.Class IIISterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
- 2014-11-26FDA-DrugMicro Labs Usa, Inc SClass IILOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
- 2014-11-26FDA-DrugAbrams Royal PharmacyClass ITrace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
- 2014-11-26FDA-DrugAbrams Royal PharmacyClass ILidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
Non-Sterility
- 2014-11-26FDA-DrugAbrams Royal PharmacyClass ICalcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
Non-Sterility: The firm's contract testing laboratory found sterility failures.
- 2014-11-26FDA-DrugPrometheus Laboratories Inc.Class IIMercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
- 2014-11-19FDA-DrugContract Packaging Resources Inc.Class IIAssured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
- 2014-11-19FDA-DrugFresenius Kabi USA LLCClass IIIHALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
- 2014-11-19FDA-DrugMicro Labs Usa, Inc SClass IIISimvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
- 2014-11-19FDA-DrugFougera Pharmaceuticals Inc.Class IIFLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
- 2014-11-12FDA-DrugApotex Inc.Class IIICandesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- 2014-11-12FDA-DrugApotex Inc.Class IIICandesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- 2014-11-12FDA-DrugApotex Inc.Class IIICandesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- 2014-11-12FDA-DrugApotex Inc.Class IIICandesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
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