Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-11-30FDA-DrugActavis Elizabeth LLCClass IIINIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
Presence of Foreign Tablets/Capsules
- 2016-11-23FDA-DrugGSK Consumer HealthcareClass IIIZeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
- 2016-11-23FDA-DrugSandoz IncClass IIL-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- 2016-11-23FDA-DrugSandoz IncClass IIL-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- 2016-11-23FDA-DrugCutisPharma, Inc.Class IIIFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- 2016-11-23FDA-DrugCutisPharma, Inc.Class IIIFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- 2016-11-23FDA-DrugAmerisource Health ServicesClass IIIBupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
- 2016-11-16FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIIClonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
- 2016-11-16FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIIClonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
- 2016-11-16FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIKamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
- 2016-11-16FDA-DrugSandoz IncClass IITransderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIIEstradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IITestosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIIEstradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIITestosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IITestosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIITestosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IITestosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 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.
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