Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-11-09FDA-DrugPharmedium Services, LLCClass IISuccinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
- 2016-11-09FDA-DrugAkorn IncClass IISodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Subpotent Drug: concentration of product is less than labeled amount.
- 2016-11-09FDA-DrugPar Pharmaceutical, Inc.Class IIIGildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Subpotent Drug; Ethinyl Estradiol
- 2016-11-09FDA-DrugPar Pharmaceutical, Inc.Class IIIGildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Subpotent Drug; Ethinyl Estradiol
- 2016-11-09FDA-DrugPar Pharmaceutical, Inc.Class IIIGildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Subpotent Drug; Ethinyl Estradiol
- 2016-11-09FDA-DrugPar Pharmaceutical, Inc.Class IIIGildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Subpotent Drug; Ethinyl Estradiol
- 2016-11-09FDA-DrugPar Pharmaceutical, Inc.Class IIIGildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Subpotent Drug; Ethinyl Estradiol
- 2016-11-09FDA-DrugActavis Laboratories, FL, Inc.Class IIIRamipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
- 2016-11-09FDA-DrugTaro Pharmaceuticals, Inc.Class IIDesoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
- 2016-11-09FDA-DrugTaro Pharmaceuticals, Inc.Class IIDesoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
- 2016-11-02FDA-DrugJanssen Ortho L.L.C.Class IIIInvokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
- 2016-11-02FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IIDIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
- 2016-11-02FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IIPersantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
- 2016-10-26FDA-DrugSupernus Pharmaceuticals, Inc.Class IITrokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
Superpotent Drug: Failure of assay specifications in the capsule.
- 2016-10-26FDA-DrugTeva Pharmaceuticals USAClass IIIPARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- 2016-10-26FDA-DrugTeva Pharmaceuticals USAClass IIIPARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- 2016-10-26FDA-DrugTeva Pharmaceuticals USAClass IIIPARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- 2016-10-26FDA-DrugDream Body Weight LossClass IIDream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- 2016-10-26FDA-DrugDream Body Weight LossClass IIDream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- 2016-10-26FDA-DrugDream Body Weight LossClass IIDream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- 2016-10-26FDA-DrugArbor Pharmaceuticals Inc.Class ICetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
- 2016-10-26FDA-DrugSOS Telecom Inc.Class ISuper Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-26FDA-DrugSOS Telecom Inc.Class IGinseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-26FDA-DrugSOS Telecom Inc.Class INinja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-26FDA-DrugSOS Telecom Inc.Class ITiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-19FDA-DrugAllergan Sales, LLCClass IITAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
Failed Content Uniformity Specifications
- 2016-10-19FDA-DrugAllergan Sales, LLCClass IITAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
Failed Content Uniformity Specifications
- 2016-10-19FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
Failed Dissolution Specifications
- 2016-10-19FDA-DrugHospira Inc., A Pfizer CompanyClass IIMarcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
- 2016-10-19FDA-DrugHospira Inc., A Pfizer CompanyClass IIMarcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
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