The Recall Desk

Archive

April 2020 recalls

605 recalls were announced in April 2020.

What the numbers show

Critical
6
Severe
113
High
182
Moderate
294
Low
10

Of the 605 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

101–200 of 605

  • SevereNHTSA·20V230000·2020-04-22

    Lode King Prestige Semi-Trailers Recalled for Cargo Winch Mount Defect

    Lode-King is recalling 2015-2021 Prestige SDG53-2 step-deck semi-trailers because cargo winch mounts may fail, allowing cargo to fall off and create road hazards.

    Product
    LODE KING — LODE KING PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2020·2020-04-22

    Encore Medical Recalls djosurgical Linear Neck Trials Due to Retaining Ring Failure

    Encore Medical is recalling 28 djosurgical Linear Neck Trials because the retaining ring has a potential to fail inter-operatively.

    Product
    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1715-2020·2020-04-22

    Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer

    Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.

    Product
    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighNHTSA·20V226000·2020-04-22

    Mercedes-Benz Recalls 2020 GLE Models Due to Air Bag Wiring Defect

    Mercedes-Benz is recalling 2020 GLE 350 and GLE 450 vehicles because a pinched wiring harness may prevent rear side air bags from deploying correctly.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2020·2020-04-22

    Smiths Medical Recalls Arterial Blood Sampling Kits with Broken Luer Defect

    Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.

    Product
    Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Food)·F-0909-2020·2020-04-22

    DSD Merchandisers Recalls Deluxe Mixed Nuts Due to Undeclared Peanuts

    DSD Merchandisers is recalling Roasted/Salted Deluxe Mixed Nuts because peanuts were included in the mix but not declared on the label.

    Product
    Roasted/Salted Deluxe Mixed Nuts; Net Wt. 10 oz./284 g, Clear plastic container UPC 65143370994 Cashews, Almonds, Brazil Nuts, Hazelnuts, Pecan Halves, Macadamia Nuts, Canola Oil, salt. Contains Tree nuts (Cashews, Almonds, Brazil Nuts, Hazelnuts, Macadamia Nuts, Pecans).
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1703-2020·2020-04-22

    Sysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard

    Sysmex America is recalling 93 CF-70 instruments because a software mismatch may prevent the device from halting when the cover door is opened.

    Product
    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2020·2020-04-22

    Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk

    Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.

    Product
    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 5899
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2020·2020-04-22

    Medtronic NavLock Tracker Recalled Due to Incorrect Assembly

    Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.

    Product
    NavLock Tracker *** Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1179-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Bi-Est8:2 Cream Due to Processing Control Issues

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Bi-Est8:2/Progesterone/Testosterone cream due to a lack of processing control. The recall affects one tube of the product.

    Product
    Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1719-2020·2020-04-22

    Canon Aquilion Lightning CT Scanner Recalled for System Shutdown Errors

    Canon Medical System is recalling six Aquilion Lightning CT scanners because a software error can interrupt scanning and prevent normal shutdown, causing loss of raw data.

    Product
    Canon Aquilion Lightning, Model TSX-036A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1189-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est Cream due to a lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1213-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream in Florida due to a lack of processing control.

    Product
    Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1186-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est Cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1707-2020·2020-04-22

    Life Technologies Recalls Ion Torrent Dx No Template Control Kit

    Life Technologies is recalling 79 units of the Ion Torrent Dx No Template Control Kit due to extended expiration dates prior to clearance.

    Product
    Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1197-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 8:2/Progesterone cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1185-2020·2020-04-22

    Estradiol 1.8 mg Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Estradiol 1.8 mg capsules due to a lack of processing control. The recall affects products distributed in Florida.

    Product
    Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1176-2020·2020-04-22

    Testosterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling 4 tubes of Testosterone Cream due to lack of processing control.

    Product
    Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1204-2020·2020-04-22

    Testosterone Gel Recalled by Florida Pharmacy for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Florida is recalling Testosterone in Atrevis 50 mg/mL Gel due to a lack of processing control.

    Product
    Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1209-2020·2020-04-22

    Estriol 5 mg Suppositories Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Estriol 5 mg Suppositories due to a lack of processing control. The affected lot is distributed in Florida.

    Product
    Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1207-2020·2020-04-22

    Clobetasol Mouth Rinse Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Clobetasol Mouth Rinse 0.05% Solution due to lack of processing control.

    Product
    Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1226-2020·2020-04-22

    Ergotamine Tartrate and Caffeine Suppositories Recalled for Processing Control Issues

    The Medicine Shoppe Pharmacy is recalling Ergotamine Tartrate and Caffeine suppositories in Florida due to a lack of processing control.

    Product
    Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1237-2020·2020-04-22

    Aurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Oxycodone and Acetaminophen tablets because they were manufactured in an area with observed water leakage.

    Product
    OXYCODONE AND ACETAMINOPHEN — OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1182-2020·2020-04-22

    Estradiol Vaginal Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Estradiol Vaginal Cream 0.01% due to lack of processing control. Affected lots were distributed in Florida.

    Product
    Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1220-2020·2020-04-22

    Paregoric Alternate Elixir Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Paregoric Alternate Elixir due to a lack of processing control.

    Product
    Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1230-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1184-2020·2020-04-22

    Testosterone Gel Recalled by Florida Pharmacy for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling specific lots of Testosterone w/ Atrevis 100 mg/mL Gel due to a lack of processing control.

    Product
    Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1726-2020·2020-04-22

    Canon Aquilion One CT Scanner Recall for System Interruption

    Canon Medical System is recalling 35 Aquilion One CT scanners because a software error may interrupt scanning and prevent normal shutdown, causing loss of raw data.

    Product
    Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1210-2020·2020-04-22

    Hydrocortisone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream due to a lack of processing control.

    Product
    Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1725-2020·2020-04-22

    Canon Aquilion Precision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.

    Product
    Canon Aquilion Precision, Model TSX-304A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1704-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test DNA Control-IVD

    Life Technologies is recalling 66 units of Oncomine Dx Target Test DNA Control-IVD because the expiration date was extended prior to clearance.

    Product
    Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error

    Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.

    Product
    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1722-2020·2020-04-22

    Canon Aquilion One Vision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans and cause loss of raw data.

    Product
    Canon Aquilion One Vision, Model TSX-301C
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1706-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test Due to Expiration Date Error

    Life Technologies is recalling 35 units of the Oncomine Dx Target Test because the expiration date was extended prior to clearance.

    Product
    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1721-2020·2020-04-22

    Canon Aquilion Premium CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling two Aquilion Premium CT scanners because a software error can interrupt scans and cause loss of raw data.

    Product
    Canon Aquilion Premium, Model TSX-301B
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1196-2020·2020-04-22

    Diethylstilbestrol Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Diethylstilbestrol 1 mg capsules due to a lack of processing control. The recall is limited to Florida.

    Product
    Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1696-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2020·2020-04-22

    FDA Recalls Endocuff Vision Colonoscopy Device Due to Labeling Update

    Boddingtons Plastics Ltd is recalling Endocuff Vision models ARV 110, 120, 130, and 140 to update instructions regarding contraindications and potential complications.

    Product
    Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1724-2020·2020-04-22

    Canon Aquilion Prime SP CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling 10 Aquilion Prime SP CT scanners because a software error may interrupt scanning and cause loss of raw data.

    Product
    Canon Aquilion Prime SP, Model TSX-303B
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1241-2020·2020-04-22

    Dermatone Sunscreen Recalled for Microbial Contamination

    Filltech USA is recalling Dermatone Sunscreen Lotion due to positive tests for yeast and bacteria.

    Product
    Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1224-2020·2020-04-22

    Testosterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Testosterone Cream due to a lack of processing control. The product was distributed in Florida.

    Product
    Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1211-2020·2020-04-22

    Medicine Shoppe Pharmacy Recalls Hydrocortisone and Econazole Cream Tubes

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling specific tubes of Hydrocortisone 2.5%/Econazole 1% cream due to a lack of processing control.

    Product
    Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1208-2020·2020-04-22

    Naltrexone Suspension Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg/mL Suspension due to lack of processing control. The product was distributed in Florida.

    Product
    Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1178-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Bi-Est8:2 Cream Due to Processing Control Issues

    The Medicine Shoppe Pharmacy is recalling 2 tubes of Bi-Est8:2/Progesterone/Testosterone cream in Florida due to a lack of processing control.

    Product
    Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1225-2020·2020-04-22

    Tretinoin Cream Recalled by Florida Pharmacy Due to Processing Control Issues

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Tretinoin 0.1% in Versabase Cream due to a lack of processing control.

    Product
    Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1187-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1206-2020·2020-04-22

    Hydromorphone Oral Solution Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Hydromorphone Oral 1 mg/mL Solution due to lack of processing control. The product was distributed in Florida.

    Product
    Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1246-2020·2020-04-22

    FDA Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations

    H J Harkins Company is recalling 9,000 tablets of Acetaminophen and Codeine Phosphate 300/30 mg due to cGMP deviations. The product was distributed in California and Arizona.

    Product
    Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count b
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1244-2020·2020-04-22

    B&B Pharmaceuticals Recalls Estradiol Powder Due to Foreign Material

    B&B Pharmaceuticals is recalling Estradiol USP powder because Teflon was found in the product. The recall covers 3,825 grams distributed nationwide.

    Product
    Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1190-2020·2020-04-22

    Progesterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling specific lots of Progesterone/Versa Base 20 mg Cream due to a lack of processing control.

    Product
    Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1217-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Bi-Est Versabase CR Due to Processing Control Issues

    The Medicine Shoppe Pharmacy is recalling Bi-Est (1:1)/Progesterone/Testosterone Versabase CR 90 mL bottles due to a lack of processing control. The recall affects products distributed in Florida.

    Product
    Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1177-2020·2020-04-22

    Fluorouracil Cream Recalled Due to Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Fluorouracil 4.5% Cream due to a lack of processing control. The product was distributed in Florida.

    Product
    Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1221-2020·2020-04-22

    Progesterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Progesterone/Natacream 20 mg/2% cream due to lack of processing control.

    Product
    Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1697-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1188-2020·2020-04-22

    Bi-Est Cream Recalled by Florida Pharmacy for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Port Charlotte, FL, is recalling Bi-Est cream due to a lack of processing control. The affected product is a prescription topical cream.

    Product
    Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1212-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Bi-Est Cream Due to Processing Control Issues

    The Medicine Shoppe Pharmacy is recalling Bi-Est (1:1)/Progesterone/Testosterone cream due to a lack of processing control. The affected product is distributed in Florida.

    Product
    Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1175-2020·2020-04-22

    Estriol Vaginal Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling 8 tubes of Estriol Vaginal Cream due to a lack of processing control.

    Product
    Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1193-2020·2020-04-22

    FDA Recalls Bi-Est Cream Due to Lack of Processing Control

    The FDA is recalling Bi-Est/DHEA/Testosterone cream from The Medicine Shoppe Pharmacy in Florida due to a lack of processing control.

    Product
    Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1234-2020·2020-04-22

    Aurobindo Recalls Simvastatin Tablets Due to Manufacturing Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Simvastatin 40mg tablets because they were manufactured in an area with observed water leakage.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0907-2020·2020-04-22

    Dana USA Recalls Dried Mushrooms for Undeclared Sulfites

    Dana USA Corp. is recalling DION DION Dried Mushrooms because the product label fails to declare sulfites.

    Product
    DION DION DRIED MUSHROOMS, Product Origin from Haiti, Net Wt. 1/4 oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1202-2020·2020-04-22

    FDA Recalls Bi-Est Cream Due to Lack of Processing Control

    The FDA is recalling Bi-Est cream from The Medicine Shoppe Pharmacy in Florida due to a lack of processing control.

    Product
    Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1203-2020·2020-04-22

    Bi-Est and Progesterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est/Progesterone cream tubes due to lack of processing control. The recall affects two tubes distributed in Florida.

    Product
    Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1201-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progest/DHEA cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1194-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Hydroquinone Cream Due to Processing Control Issues

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid cream due to a lack of processing control.

    Product
    Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1200-2020·2020-04-22

    Bi-Est 1:1/Progest/DHEA Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream due to lack of processing control.

    Product
    Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1229-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1708-2020·2020-04-22

    United Imaging uMI 550 PET/CT System Recalled for Software Bugs

    Shanghai United Imaging Healthcare is recalling two uMI 550 PET/CT systems due to software bugs that may cause reconstruction problems and patient rescans.

    Product
    Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1222-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Testosterone Gel Due to Processing Control Issues

    The Medicine Shoppe Pharmacy is recalling specific lots of Testosterone in Atrevis 75 mg/mL Gel due to a lack of processing control. The affected product was distributed in Florida.

    Product
    Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1218-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1720-2020·2020-04-22

    Canon Aquilion One CT Scanner Recalled for Scanning Interruption Errors

    Canon Medical System is recalling two Aquilion One CT scanners because scanning errors may interrupt exams and force system reboots, resulting in the loss of acquired raw data.

    Product
    Canon Aquilion One, Model TSX-301A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1698-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 43 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1195-2020·2020-04-22

    Ergotamine Tartrate Suppositories Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Ergotamine Tartrate and Caffeine suppositories due to a lack of processing control.

    Product
    Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1199-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progesterone/Testosterone cream due to a lack of processing control.

    Product
    Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1180-2020·2020-04-22

    Naltrexone Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg capsules due to a lack of processing control.

    Product
    Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1242-2020·2020-04-22

    Dermatone Sunscreen Recalled for Microbial Contamination

    Filltech USA is recalling Dermatone Sunscreen Lotion SPF 50 due to positive tests for yeast and bacteria.

    Product
    Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Be
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1205-2020·2020-04-22

    Paregoric Compound Solution Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Port Charlotte, FL, is recalling Paregoric Compound Solution due to a lack of processing control.

    Product
    Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1191-2020·2020-04-22

    Progesterone 200 mg Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling specific lots of Progesterone 200 mg Capsules due to a lack of processing control.

    Product
    Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1227-2020·2020-04-22

    Betahistine 16 mg Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Betahistine 16 mg capsules due to lack of processing control. The recall affects 2 bottles distributed in Florida.

    Product
    Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1216-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream due to a lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1702-2020·2020-04-22

    Merit Medical Recalls Nonsterile ChloraPrep Applicators for Vein Trays

    Merit Medical Systems is recalling six units of nonsterile ChloraPrep applicators that were inadvertently shipped to a customer in Illinois.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1219-2020·2020-04-22

    FDA Recalls Estriol/Testosterone Vaginal Cream Due to Processing Control Issues

    The FDA is recalling Estriol/Testosterone Vaginal 0.1/0.1% Cream from The Medicine Shoppe Pharmacy in Florida due to a lack of processing control.

    Product
    Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1723-2020·2020-04-22

    Canon Aquilion Prime CT Scanner Recalled for System Shutdown Errors

    Canon Medical System is recalling 10 Aquilion Prime CT scanners because a software error may interrupt scanning and prevent normal shutdown, resulting in data loss.

    Product
    Canon Aquilion Prime, Model TSX-303A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1183-2020·2020-04-22

    Testosterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Testosterone w/ Atrevis 20 mg (2%) Cream due to lack of processing control.

    Product
    Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1231-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1714-2020·2020-04-22

    Greiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency

    Greiner Bio-One is recalling VACUETTE 2mL 9NC Coagulation Tubes because the sodium citrate anticoagulant levels were inconsistent. The recall affects 1,000,800 units distributed nationwide.

    Product
    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1192-2020·2020-04-22

    Bi-Est 1:1 Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progesterone/Testosterone cream due to lack of processing control.

    Product
    Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1223-2020·2020-04-22

    Ketoprofen/DMSO Lipoderm Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jars due to lack of processing control.

    Product
    Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1695-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1713-2020·2020-04-22

    CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error

    CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.

    Product
    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1694-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0923-2020·2020-04-22

    CT Health Solutions Recalls Lycopene Dietary Supplement Due to Low Potency

    CT Health Solutions is recalling 1,500 bottles of We Like Vitamins Lycopene 50 mg dietary supplement because the product was found to have low potency.

    Product
    We Like Vitamins, Lycopene 50 mg, Dietary Supplement, 200 Capsules
    Category
    Food
    Distribution
    1 state

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