The Recall Desk

Archive

August 2020 recalls

436 recalls were announced in August 2020.

What the numbers show

Critical
25
Severe
118
High
163
Moderate
122
Low
8

Of the 436 recalls this month scored against our rubric, 6% are Critical, 27% are Severe.

401–436 of 436

  • ModerateFDA (Drugs)·D-1435-2020·2020-08-05

    MasterPharm Recalls Sildenafil Troches Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Sildenafil 50 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1430-2020·2020-08-05

    MasterPharm Recalls Progesterone Tablets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling specific lots of Progesterone 150 mg tablets because they lack assurance of conformity to specifications.

    Product
    Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1443-2020·2020-08-05

    MasterPharm Recalls Yohimbine HCL Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Yohimbine HCL 5.4mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1438-2020·2020-08-05

    MasterPharm Recalls Tadalafil 26 mg Capsules Due to Processing Controls

    MasterPharm LLC is recalling Tadalafil 26 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1420-2020·2020-08-05

    MasterPharm Recalls Estriol 6 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Estriol 6 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1035-2020·2020-08-05

    Built Brands Recalls Moldy Banana Chocolate Creme Protein Bars

    Built Brands LLC is recalling 79,500 Banana Chocolate Creme protein bars because they may be moldy before the expiration date.

    Product
    Banana Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1426-2020·2020-08-05

    MasterPharm Recalls Minoxidil/Biotin/Spironolactone Capsules Due to Processing Controls

    MasterPharm LLC is recalling Minoxidil/Biotin/Spironolactone capsules nationwide due to a lack of processing controls and assurance of conformity to specifications.

    Product
    Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2020·2020-08-05

    TTDEYE Flower Grey Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Grey colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2020·2020-08-05

    Synthes Recalls MatrixMIDFACE Screws Due to Incorrect Size Marking

    Synthes Produktions GmbH is recalling 41 units of MatrixMIDFACE Screws because the body clip was etched with the wrong size number.

    Product
    MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1409-2020·2020-08-05

    Allergan Recalls Subpotent Skin Medica Acne Treatment Lotion

    Allergan is recalling specific lots of Skin Medica Acne Treatment Lotion because the products failed potency tests at 12 and 24 months.

    Product
    Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1442-2020·2020-08-05

    MasterPharm Recalls Vardenafil Troches Due to Lack of Processing Controls

    MasterPharm LLC is recalling Vardenafil 20 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1423-2020·2020-08-05

    MasterPharm Recalls Formula 82F Minoxidil Tretinoin Fluocinolone Acetonide Finasteride

    MasterPharm LLC is recalling 462 units of Formula 82F topical solution due to a lack of processing controls that compromised product specifications.

    Product
    Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1424-2020·2020-08-05

    MasterPharm Recalls Formula 82M Due to Lack of Processing Controls

    MasterPharm LLC is recalling 543 units of Formula 82M topical solution nationwide because the product lacks assurance of conformity to specifications.

    Product
    Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1037-2020·2020-08-05

    Built Brands Recalls Cookie Dough Protein Bars for Potential Mold

    Built Brands LLC is recalling specific lots of Cookie Dough Chocolate covered protein bars because they may be moldy before the expiration date.

    Product
    Cookie Dough Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2020·2020-08-05

    Steris InnoWave Sonic Irrigator Recalled for Unclear Installation Test Criteria

    Steris Corporation is recalling 1,283 InnoWave Sonic Irrigators because an FDA inspection found that the foil test performed during installation lacks clear acceptance criteria.

    Product
    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1041-2020·2020-08-05

    Built Brands Recalls Black Cherry Chocolate Creme Protein Bars for Mold

    Built Brands LLC is recalling 121,190 Black Cherry Chocolate Creme protein bars because they may be moldy before the expiration date.

    Product
    Black Cherry Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1428-2020·2020-08-05

    MasterPharm Recalls Progesterone Troches Due to Processing Control Deficiencies

    MasterPharm LLC is recalling specific lots of Progesterone 150 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1432-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Progesterone 50 mg Modified Release Capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2020·2020-08-05

    Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction

    Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.

    Product
    regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1418-2020·2020-08-05

    MasterPharm Recalls Calcium Citrate Powder Due to Processing Control Deficiencies

    MasterPharm LLC is recalling 24 grams of Calcium citrate tetrahydrate USP powder due to a lack of processing controls that ensures conformity to specifications.

    Product
    Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1437-2020·2020-08-05

    MasterPharm Recalls Tadalafil 18 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 18 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1411-2020·2020-08-05

    Hand Sanitizer Recalled for Subpotent Alcohol and High pH Levels

    World Event Promotions, LLC is recalling Handese Advanced Instant Hand Sanitizer because the product was found to be subpotent and has high pH levels.

    Product
    Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2020·2020-08-05

    Sun Pharmaceutical Recalls Clonazepam Tablets Due to Cross-Contamination

    Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets because routine stability testing detected cross-contamination with clozapine.

    Product
    Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1421-2020·2020-08-05

    MasterPharm Recalls Estriol 8 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Estriol 8 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2020·2020-08-05

    Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve

    Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.

    Product
    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1422-2020·2020-08-05

    MasterPharm Recalls Finasteride Plus Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Finasteride Plus 1.25mg capsules nationwide because the product lacked processing controls to ensure it met specifications.

    Product
    Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1433-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling 600 capsules of Progesterone Modified Release 100 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2698-2020·2020-08-05

    Synthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling

    Synthes, Inc. is recalling 104 units of MatrixNEURO 5mm screws because the body clip is etched with '4', incorrectly indicating a 4mm screw, despite correct outer packaging.

    Product
    MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1441-2020·2020-08-05

    MasterPharm Recalls Testosterone/Anastrozole Pellets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Testosterone/Anastrozole Pellets 100/6 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419 (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2706-2020·2020-08-05

    Richard Wolf Recalls Tube Set for Transanal Endoscopic Microsurgery

    Richard Wolf GmbH is recalling 338 Tube Sets for TEM because smaller diameter tube material was used. The affected units were distributed internationally.

    Product
    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1410-2020·2020-08-05

    Allergan Recalls Skin Medica Acne System Kits for Subpotency

    Allergan is recalling 8,555 Skin Medica Acne System kits nationwide because the products failed potency tests at 12 and 24 months.

    Product
    Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V454000·2020-08-04

    Indian Recalls 2019 Scout Motorcycles Due to Brake Performance Issues

    Indian Motorcycle is recalling 2019 Scout, Scout Sixty, and Scout Bobber models because trapped air in the brake system may reduce performance and increase crash risk.

    Product
    INDIAN — INDIAN SCOUT BOBBER, SCOUT, SCOUT SIXTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V453000·2020-08-04

    2019 Mercedes-Benz Sprinter Recalled for Fuel Pump Leak Risk

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because an open port on the fuel pump may leak fuel onto the roadway, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V451000·2020-08-03

    Triumph Recalls 2020 Tiger 900 Models for Detaching Rear Reflectors

    Triumph is recalling 2020 Tiger 900 motorcycles because rear reflectors may detach, reducing visibility and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH TIGER 900 RALLY, TIGER 900, TIGER 900 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V452000·2020-08-03

    Bentley Recalls 2020 Flying Spur for Rear Camera Moisture Issue

    Bentley is recalling 2020 Flying Spur vehicles because moisture can enter the rear camera holder, reducing image clarity and increasing crash risk.

    Product
    BENTLEY — BENTLEY FLYING SPUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08012020·2020-08-01

    USDA Alert: Frozen Taquitos and Chimichangas May Contain Hard Plastic

    USDA FSIS issued a public health alert for frozen taquitos and chimichangas that may contain hard plastic from recalled green chilies.

    Product
    Ajinomoto Foods North America — FSIS Issues Public Health Alert for Meat and Poultry Taquitos and Chimichangas Containing FDA-Regulated Diced Green Chilies That Have Been Recalled Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide

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