March 21, 2018DrugsFDA
Pfizer Inc. recalls Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mf
Hazard: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
March 21, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 5859
Hazard: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
March 21, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Hazard: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
March 21, 2018DrugsFDA
Alva-Amco Pharmacal Companies., Inc. recalls Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by
Hazard: Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Ph
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 21, 2018DrugsFDA
Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pha
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 14, 2018DrugsFDA
Mckesson Packaging Services recalls RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 1
Hazard: Failed Stability Specifications
March 14, 2018DrugsFDA
SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 -
Hazard: Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
March 14, 2018DrugsFDA
Bella All Natural recalls Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
Hazard: Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
March 14, 2018DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bo
Hazard: Labeling: Label mix-up
March 14, 2018DrugsFDA
AstraZeneca Pharmaceuticals LP recalls Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmin
Hazard: Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
March 14, 2018DrugsFDA
Oxygen Development Llc recalls Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmapr
Hazard: Superpotent drug: failed assay throughout the stick after 6 months stability.
March 14, 2018DrugsFDA
Spirit Pharmaceuticals, LLC recalls Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779,
Hazard: CGMP deviations: Ibuprofen is being recalled in response to previous recall
March 14, 2018DrugsFDA
Kalchem International, Inc. recalls Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx an
Hazard: cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
March 14, 2018DrugsFDA
Osmotica Pharmaceutical Corp recalls Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC
Hazard: Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
March 14, 2018DrugsFDA
Apollo Care recalls Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbi
Hazard: Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
March 14, 2018DrugsFDA
Apollo Care recalls Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia,
Hazard: Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
March 14, 2018DrugsFDA
Akorn, Inc. recalls Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Fores
Hazard: Failed Stability Specification: OOS low viscosity results discovered during retain testing.
March 14, 2018DrugsFDA
Hospira Inc. A Pfizer Company recalls Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, I
Hazard: Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
March 7, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufacture
Hazard: Presence of Particulate Matter; contains visible particulate matter identified as mold.
March 7, 2018DrugsFDA
Kareway Products Inc recalls GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care
Hazard: Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
March 7, 2018DrugsFDA
LEADIANT BIOSCIENCES, INC recalls Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amit
Hazard: Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
March 7, 2018DrugsFDA
B. Braun Medical Inc recalls 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine,
Hazard: Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
March 7, 2018DrugsFDA
Fagron, Inc recalls SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron
Hazard: Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
March 7, 2018DrugsFDA
Medline Industries Inc recalls PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by
Hazard: Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
March 7, 2018DrugsFDA
ALLERGAN recalls INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (ND
Hazard: Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
March 7, 2018DrugsFDA
Apace KY LLC recalls Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15],
Hazard: Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-80
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.