Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-01-03FDA-DrugSimple Diagnostics, Inc.Class IIAlcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Lack of Assurance of Sterility and cGMP Deviations
- 2018-01-03FDA-DrugKeryx Biopharmaceuticals, Inc.Class IIIAuryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
- 2018-01-03FDA-DrugPharmedium Services, LLCClass IIIHYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2018-01-03FDA-DrugPharmedium Services, LLCClass IIImorphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2018-01-03FDA-DrugPharmedium Services, LLCClass IIImorphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2017-12-27FDA-DrugVital Rx, Inc. dba Atlantic Pharmacy and CompoundingClass IIAll Sterile Products within expiry
Lack of Assurance of Sterility .
- 2017-12-27FDA-DrugPremier Pharmacy Labs IncClass IINeostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
- 2017-12-27FDA-DrugL. Perrigo CompanyClass IIMaximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01
Microbial Contamination of Non-Sterile Products
- 2017-12-27FDA-DrugClaris Lifesciences IncClass IIICiprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
Superpotent
- 2017-12-27FDA-DrugThe Ampt Life, LLCClass INATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
- 2017-12-27FDA-DrugTeva Pharmaceuticals USAClass IIAmethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
- 2017-12-27FDA-DrugRenaissance Lakewood, LLCClass IIIFluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
Superpotent
- 2017-12-27FDA-DrugPfizer Inc.Class IVancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Presence of Particulate Matter: glass particulate found in vial
- 2017-12-27FDA-DrugEZWeightLossTX LLCClass ILaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- 2017-12-27FDA-DrugEZWeightLossTX LLCClass ILaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- 2017-12-27FDA-DrugAmneal Pharmaceuticals of New York, LLCClass ILorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class IINitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class IINitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class IINitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class IINitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class INitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
Subpotent Drug: found to be below the specification for labeled assay.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class INitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
Subpotent Drug: found to be below the specification for labeled assay.
- 2017-12-27FDA-DrugAdvanced Pharma Inc.Class INitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Subpotent Drug: found to be below the specification for labeled assay.
- 2017-12-27FDA-DrugB. Braun Medical IncClass II0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
- 2017-12-27FDA-DrugOsmotica Pharmaceutical CorpClass IIIMethylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
Subpotent Drug
- 2017-12-27FDA-DrugOsmotica Pharmaceutical CorpClass IIIMethylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
Subpotent Drug
- 2017-12-20FDA-DrugSun Pharmaceutical Industries, Inc.Class IIRiomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512
Microbial Contamination of Non-Sterile Products
- 2017-12-20FDA-DrugTeva Pharmaceuticals USAClass IIIPenicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
- 2017-12-13FDA-DrugElite Laboratories Inc.Class IIIIsradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
Failed Impurities/Degradation Specifications
- 2017-12-13FDA-DrugGadget Island, IncClass Igrande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
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