The Recall Desk

FDA (Drugs) recall action 82754

Unipharma, Llc. recalled 11 products on 2019-05-22

The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products
11
Announced
2019-05-22
Critical
0
Units
202,988

Why these products were recalled

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

  • ModerateFDA (Drugs)··2019-05-22

    CVS Health Children's Nasal Saline Drops Recalled for B. cepacia Risk

    Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
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    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
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    0 states
  • ModerateFDA (Drugs)··2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma, LLC is recalling CVS Health Children's Cough Syrup due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
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    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-05-22

    DrKids Nasal Saline Vials Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
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    0 states
  • ModerateFDA (Drugs)··2019-05-22

    DrKids Children's Pain & Fever Oral Solution Recalled for B. cepacia Risk

    Unipharma, LLC is recalling 280 cartons of DrKids Children's Pain & Fever Oral Solution due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
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    0 states
  • ModerateFDA (Drugs)··2019-05-22

    CVS Children's Acetaminophen Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Pain & Fever Acetaminophen single-use vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
    Category
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    0 states
  • ModerateFDA (Drugs)··2019-05-22

    DrKids Children's Allergy Relief Diphenhydramine Recalled for B. cepacia Contamination Risk

    Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine HCl due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010
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    0 states
  • ModerateFDA (Drugs)··2019-05-22

    CVS Children's Allergy Liquid Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-05-22

    CVS Health Children's Mucus Relief Recalled for B. cepacia Contamination Risk

    Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-26
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01,
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Natural Cough Syrup due to potential contamination with B. cepacia bacteria. This is a precautionary measure.

    Product
    DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
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    0 states