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.
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIBupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-12FDA-DrugPharmedium Services LlcClass IIIRopivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2017-07-05FDA-DrugAllergan Sales, LLCClass IIBlephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
- 2017-07-05FDA-DrugMckesson Packaging ServicesClass IIIBuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
Failed Moisture Limits: Product tested out-of-specification for moisture content.
- 2017-07-05FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIDoxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
- 2017-07-05FDA-DrugSanofi-Aventis U.S. LLCClass IIIGaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Superpotent Drug: high out-of-specification result for magnesium.
- 2017-07-05FDA-DrugL. Perrigo CompanyClass IIIWalgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
- 2017-07-05FDA-DrugApothecary By DesignClass IIProgesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
- 2017-07-05FDA-DrugNoven Pharmaceuticals, Inc.Class IIIMinivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
- 2017-06-28FDA-DrugVi-Jon, Inc.Class IIMagnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344
Presence of foreign substance: glass particle
- 2017-06-28FDA-DrugLucid Pharma LLCClass IIVenlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
- 2017-06-21FDA-DrugMylan Pharmaceuticals Inc.Class IIIMontelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
- 2017-06-21FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
cGMP Deviations; lack of quality assurance.
- 2017-06-21FDA-DrugComplete Pharmacy and Medical Solutions LLCClass IHuman Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
- 2017-06-21FDA-DrugComplete Pharmacy and Medical Solutions LLCClass IHuman Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIVANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIVANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIVANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIPotassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
- 2017-06-21FDA-DrugPharmedium Services, LLCClass IIIPotassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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