Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Pain Relief & OTC Medication Recalls
Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class III · Low risk
TRAMADOL HYDROCHLORIDE Tablets
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Class II · Moderate risk
Major Extra Strength Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk
Leader Extra Strength Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class III · Low risk
Tramadol Hydrochloride Tablets USP CIV
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Gabapentin Capsules
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
S-Calm Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Altaire Diclofenac Sodium Opthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Altaire Diclofenac Sodium Opthalmic Solution
Lack of Assurance of Sterility
Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class II · Moderate risk
Acetaminophen Children's Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Pain & Fever Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Mapap Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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