Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1228

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

DrugJun 19, 2019

SELECT DISTRIBUTIONS Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count recall — FDA D-1344-2019

Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil

Class IFDA: TerminatedSELECT DISTRIBUTIONS LLC

DrugJun 19, 2019

Torrent Pharma Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant recall — FDA D-1353-2019

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 Acetic Acid Otic Solution, USP, 2% recall — FDA D-1362-2019

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 Cough Formula Expectorant recall — FDA D-1349-2019

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 Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC recall — FDA D-1374-2019

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 Anu-Med brand of Hemorrhoidal Suppositories recall — FDA D-1379-2019

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 1 mg/mL, For Oral Use Only recall — FDA D-1380-2019

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 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 recall — FDA D-1384-2019

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-1382-2019

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 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 recall — FDA D-1383-2019

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 Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor recall — FDA D-1352-2019

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 Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic recall — FDA D-1368-2019

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 Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol recall — FDA D-1346-2019

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 Hemorrhoidal Suppositories recall — FDA D-1378-2019

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 Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration recall — FDA D-1373-2019

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

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection recall — FDA D-1343-2019

Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP…

Class IIFDA: TerminatedB. Braun Medical Inc.

DrugJun 19, 2019

Torrent Pharma Extra Action Cough Syrup recall — FDA D-1369-2019

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

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec recall — FDA D-1395-2019

Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states…

Class IFDA: TerminatedNovis PR, Inc.

DrugJun 19, 2019

Torrent Pharma Hyoscyamine Oral Drops 0.125 mg/mL recall — FDA D-1359-2019

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

Class IIFDA: TerminatedTorrent Pharma Inc.

DrugJun 19, 2019

AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial recall — FDA D-1398-2019

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 Memantine Hydrochloride Oral Solution, 2 mg/mL recall — FDA D-1375-2019

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 Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal recall — FDA D-1367-2019

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 Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 recall — FDA D-1371-2019

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

Class IIFDA: TerminatedTorrent Pharma Inc.

VehicleJun 19, 2019

Volkswagen Group of inflator module recall — NHTSA campaign 19V473000

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Audi Q5 and SQ5 vehicles. In the event of a crash deploying the passenger's frontal air bag, the instrument panel…

inflator moduleVolkswagen Group of America, Inc.

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