Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IISufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIHydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIHydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIBaclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-09FDA-DrugSun Pharma Global FzeClass IIAlendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
- 2016-03-09FDA-DrugJ. Strickland and CoClass IIIsulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654
Subpotent Drug: failed at the 3 and 6 month stability time points.
- 2016-03-09FDA-DrugTexasStar PharmacyClass IIBaclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
Lack of assurance of sterility
- 2016-03-09FDA-DrugTeva North AmericaClass IICapecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
Failed Dissolution Specifications: low test results at the 18 month time-point
- 2016-03-09FDA-DrugBaxter Healthcare Corp.Class II0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
- 2016-03-09FDA-DrugGenzyme CorporationClass IIThyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- 2016-03-09FDA-DrugGenzyme CorporationClass IIThyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- 2016-03-02FDA-DrugIsomeric Pharmacy Solution, LLCClass IIITriamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
- 2016-03-02FDA-DrugHospira Inc.Class IIINormosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
- 2016-03-02FDA-DrugKeystone Laboratories IncClass IIMedicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5.
Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
- 2016-03-02FDA-DrugZydus Pharmaceuticals USA IncClass IIIrisperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
- 2016-02-24FDA-DrugPharmedium Services, LLCClass IfentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
Subpotent Drug
- 2016-02-24FDA-DrugPharmedium Services, LLCClass IfentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
Subpotent Drug
- 2016-02-24FDA-DrugFit Firm and FabulousClass IUltimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.
- 2016-02-24FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIParicalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- 2016-02-24FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIParicalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- 2016-02-24FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIParicalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IItestosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IItestosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIprogesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
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