Class II · Moderate risk
Altaire Ciprofloxacin Ophthalmic Solution
Lack of Assurance of Sterility
Antibiotic Recalls
Recalls of antibiotics used to treat bacterial infections.
197 recalls in this category, newest first.
Class II · Moderate risk
Altaire Ciprofloxacin Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Clindamycin 900 mg in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Class II · Moderate risk
Penicillin G 100
Lack of sterility assurance.
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class II · Moderate risk
Cephalexin for Oral Suspension USP 250mg/5 mL
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Class II · Moderate risk
Cephalexin for Oral Suspension USP
CGMP Deviation; manufacturing batch record could not be located
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class II · Moderate risk
Doxycycline Hyclate USP Tablets
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications:
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications:
Class II · Moderate risk
Clindamycin 300 mg capsules
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Clindamycin 150 mg capsules
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Doxycycline Hyclate USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Clindamycin Phosphate USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Penicillin V Potassium for Oral Solution
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
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