Class III · Low risk
Amoxicillin For Oral Suspension
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Antibiotic Recalls
Recalls of antibiotics used to treat bacterial infections.
197 recalls in this category, newest first.
Class II · Moderate risk
Metronidazole 500mg Tablet
CGMP Deviations
Class II · Moderate risk
Doxycycline100mg Tablets
CGMP Deviations
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class III · Low risk
Ciprofloxacin OPTH 0.3% SOL
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class III · Low risk
Doxycycline
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Class II · Moderate risk
Clindamycin 900 mg in 100 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
All doxycycline Products
Lack of Processing Controls
Class III · Low risk
Ciprofloxacin Ophthalmic Solution
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Class I · High risk
Metronidazole Injection USP
Presence of Particulate Matter: identified as a cloth fiber.
Class II · Moderate risk
Clindamycin injection
Lack of Assurance of Sterility
Class II · Moderate risk
CLINDAMYCIN 120MG in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
PENICILLIN in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Labeling: Wrong Bar Code
Class II · Moderate risk
Doxycycline/0.9% NaCl 300 mg/500 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Doxycycline/0.9% NaCl 150 mg/250 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Doxycycline/0.9 % NaCl 100 mg/100 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Ciprofloxacin 400mg / D5w 200ml Accuflo
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Azithromycin 500 mg tablets
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin Tablets
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
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