Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
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
Ibuprofen Tablets
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Class II · Moderate risk
Alka-Seltzer Extra Strength
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk
Alka-Seltzer Original
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk
Aspirin Chewable Tablets
Presence of Foreign Substance: foreign material found in the bulk inventory.
Class II · Moderate risk
Ofirmev (Acetaminophen)
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
HealthA2Z CHEWABLE Aspirin
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class II · Moderate risk
DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I · High risk
Ibuprofen Lysine Injection
Presence of Particulate Matter
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Ninjacof-A
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Acetaminophen 325mg tablets
CGMP Deviations
Class III · Low risk
Acetaminophen & Codeine Phosphate Tablets
Labeling: Not elsewhere classified - count on the label was incorrect.
Class III · Low risk
SKY Aspirin Chewable Tablets
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class II · Moderate risk
All Midrin
Lack of Processing Controls
Class II · Moderate risk
All lidocaine
Lack of Processing Controls
Class I · High risk
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class I · High risk
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class II · Moderate risk
Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg)
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Class III · Low risk
Panadol (acetaminophen)
Failed Dissolution Specifications
Class II · Moderate risk
Meloxicam capsules
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class I · High risk
Mucinex Fast-Max Cold & Sinus
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Night Time Cold & Flu
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Cold
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class II · Moderate risk
Ibuprofen 10% cream
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
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