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.
- 2016-12-28FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IHyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- 2016-12-28FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IHyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- 2016-12-28FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IHyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- 2016-12-28FDA-DrugGuardian Pharmacy ServicesClass ILidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Non-Sterility: failed sterility test result.
- 2016-12-28FDA-DrugUltimate Body ToxClass IUltimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of 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 for which safety and efficacy have not been established and therefore subject to recall.
- 2016-12-28FDA-DrugColonia Care PharmacyClass IIC-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
- 2016-12-28FDA-DrugColonia Care PharmacyClass IIC-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
- 2016-12-28FDA-DrugZydus Pharmaceuticals USA IncClass IIIBuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Failed Dissolution Specifications; 6 month time point
- 2016-12-28FDA-DrugBaxter Healthcare CorporationClass IIFluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
- 2016-12-21FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIMethylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IISuccinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIRopivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIRocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIOxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IINeostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIMorphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIMidazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IILidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIHydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIHYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIHYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIHeparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIHeparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIFentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIFentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIFentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IICalcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IICalcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-102-09
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIPhenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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