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.
- 2017-08-23FDA-DrugDYNAMIC TECHNICAL FORMULATIONSClass IBiotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
- 2017-08-23FDA-DrugAmgen, Inc.Class IIProcrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
- 2017-08-23FDA-DrugHARDCORE FORMULATIONSClass ID-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- 2017-08-23FDA-DrugHARDCORE FORMULATIONSClass IULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- 2017-08-23FDA-DrugKVK-Tech, Inc.Class IIIPhentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
- 2017-08-16FDA-DrugHOSPIRA INC, LAKE FORESTClass IIHydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.
Presence of Particulate Matter: Silicone oil
- 2017-08-16FDA-DrugHOSPIRA INC, LAKE FORESTClass IIHydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
Presence of Particulate Matter: Silicone oil
- 2017-08-16FDA-DrugHOSPIRA INC, LAKE FORESTClass IIHydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01
Presence of Particulate Matter: Silicone oil
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIRocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IINeostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIAdenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IISodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIPhenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIDiltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IINorepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IINorepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IINorepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IISuccinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IISuccinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugAtHome Medical, Inc.Class IIOxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
- 2017-08-16FDA-DrugX-Gen Pharmaceuticals Inc.Class IINystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Presence of Foreign Substance: potential presence of plastic particles.
- 2017-08-16FDA-DrugTeva Pharmaceuticals USAClass IIIGlipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
- 2017-08-09FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIFamotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Failed Tablet/Capsule Specification: out of specification for tablet weight.
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