November 29, 2017DrugsFDA
Ridge Properties, LLC recalls Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06
Hazard: GMP Deviations: inadequate manufacturing control processes
November 29, 2017DrugsFDA
Leading Pharma, LLC recalls Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004
Hazard: Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
November 29, 2017DrugsFDA
Shata Trading, Inc. recalls No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th
Hazard: Marketed Without an Approved NDA/ANDA
November 29, 2017DrugsFDA
United Therapeutics Corp. recalls TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit M
Hazard: CGMP Deviations
November 22, 2017DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmace
Hazard: Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
November 22, 2017DrugsFDA
Llorens Pharmaceutical Corp. recalls Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyo
Hazard: Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
November 22, 2017DrugsFDA
PharMEDium Services, LLC. recalls Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Servi
Hazard: Superpotent drug: out of specification result for potency
November 22, 2017DrugsFDA
Fagron, Inc recalls Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2)
Hazard: cGMP Deviations: lack of quality assurance at the API manufacturer.
November 22, 2017DrugsFDA
Allergan Sales, LLC recalls Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Hazard: Failed Impurities/Degradation Specifications.
November 22, 2017DrugsFDA
Allergan Sales, LLC recalls Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-
Hazard: Failed Impurities/Degradation Specifications.
November 22, 2017DrugsFDA
Amneal Pharmaceuticals LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Am
Hazard: Presence of Particulate Matter
November 22, 2017DrugsFDA
Genzyme Corporation recalls Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg
Hazard: Labeling: Incorrect or Missing Package Insert.
November 22, 2017DrugsFDA
Amerisource Health Services recalls Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Pac
Hazard: Failed Stability Specifications
November 15, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube,
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
November 15, 2017DrugsFDA
Ace Surgical Supply Co., Inc. recalls Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
November 15, 2017DrugsFDA
Purdue Pharma, LP recalls Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 6
Hazard: Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
November 8, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count
Hazard: Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceutica
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceutica
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml T
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 7220
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphin
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride s
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) R
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
SCA Pharmaceuticals, LLC recalls SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA P
Hazard: Lack Of Assurance Of Sterility.
November 8, 2017DrugsFDA
Kiriko, LLC. recalls A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SL
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
November 8, 2017DrugsFDA
Precision Dose Inc. recalls Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tr
Hazard: Subpotent Drug: low out of specification results.
November 8, 2017DrugsFDA
Sanofi-Aventis U.S. LLC recalls Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The
Hazard: Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.