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Showing 1–20 of 26 results

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NaturalCare Allergy Drops (Nutraceutical) – raw material discoloration (2023)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

FDAFeb 23, 2023Nationwide• Nutraceutical Corporation

Children's Cough Syrup (Plastikon) - Manufacturing Deviation (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

CorrectDose Children's Allergy Relief (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class II

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Peppermint Lip Moisturizer (Yusef) – Ingredient Overdose (2020)

Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.

FDAMar 3, 2020Nationwide• Yusef Manufacturing Laboratories, LLC

DrKids Cough Syrup (Unipharma) – bacteria risk (2019)

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

FDASep 23, 2019Nationwide• Unipharma, Llc.

Children's Nasal Saline Drops (CVS Health) – Bacterial Contamination (2019)

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

FDAJul 15, 2019Nationwide• Unipharma, Llc.

Children's Allergy Relief (DrKids) – Bacterial Contamination (2019)

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

FDAJul 15, 2019Nationwide• Unipharma, Llc.

Children's Allergy Relief Liquid (CVS Health) – Bacterial Contamination (2019)

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

FDAJul 15, 2019Nationwide• Unipharma, Llc.

CVS Children's Mucus Relief (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

CVS Children's Nasal Drops (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

DrKids Allergy Relief (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

CVS Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

CVS Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

CVS Children's Allergy Liquid (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

DrKids Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

DrKids Natural Cough Syrup (Unipharma) – Bacteria Risk (2019)

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

FDAMay 2, 2019Nationwide• Unipharma, Llc.

CVS Health Sterile Saline Nasal Mist (Product Quest) - Manufacturing Quality Issues (2018)

CGMP Deviations: products manufactured under conditions that could impact its product quality.

FDAAug 3, 2018Nationwide• Product Quest Manufacturing LLC

Children's Appetite & Weight (King Bio) – Microbial Contamination (2018)

Microbial contamination

FDAJul 20, 2018Nationwide• King Bio Inc.

Children's Appetite Enhancer (King Bio) – Microbial Contamination (2018)

Microbial contamination

FDAJul 20, 2018Nationwide• King Bio Inc.

Children's Fever Reliever (King Bio) – Microbial Risk (2018)

Microbial contamination

FDAJul 20, 2018Nationwide• King Bio Inc.

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