Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1227

The newest recall records with useful source details are listed here.

FoodJun 19, 2019

Wismettac Asian Foods CHOCOLATE ALMOND CHOCOLATE MEIJI, 3.1 oz recall — FDA F-1451-2019

Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.

Class IIFDA: TerminatedWismettac Asian Foods, Inc.

DrugJun 19, 2019

Torrent Pharma Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton recall — FDA D-1357-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough recall — FDA D-1356-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. recall — FDA D-1354-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol recall — FDA D-1347-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial recall — FDA D-1397-2019

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

Class IFDA: TerminatedHeritage Pharmaceuticals, Inc.

DrugJun 19, 2019

Torrent Pharma Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL recall — FDA D-1360-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Phenobarbital Oral Solution, USP, 20 mg per 5 mL recall — FDA D-1365-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Robafen DM Syrup recall — FDA D-1351-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. recall — FDA D-1370-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD recall — FDA D-1361-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Robafen DM Cough Sugar-Free Clear Cough Expectorant recall — FDA D-1355-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only recall — FDA D-1381-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Estradiol Vaginal Inserts USP 10 mcg recall — FDA D-1340-2019

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA

DrugJun 19, 2019

Torrent Pharma Lactulose Solution, USP 10 g/15 mL, For Oral Administration recall — FDA D-1372-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Guaifenesin AC Cough Syrup recall — FDA D-1363-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL recall — FDA D-1358-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Pain & Fever Oral Solution recall — FDA D-1366-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Robafen AC Oral Solution recall — FDA D-1350-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma RisperiDONE Oral Solution, USP, 1 mg/mL recall — FDA D-1345-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per recall — FDA D-1377-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Hydrocortisone Acetate Suppositories, 25 mg recall — FDA D-1376-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol recall — FDA D-1348-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Torrent Pharma Guaifenesin DAC Oral Solution, Sugar free recall — FDA D-1364-2019

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIFDA: TerminatedTorrent Pharma Inc.

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