Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Antibiotic Recalls
Recalls of antibiotics used to treat bacterial infections.
197 recalls in this category, newest first.
Class II · Moderate risk
CSF Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
Clindamycin and Benzoyl Peroxide Gel
Superpotent Drug
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Class II · Moderate risk
PENICILLIN V POT for Oral Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
CIPRODEX (Ciprofloxacin 0.3 and Dexamethasone 0.1%)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amoxicillin 500mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Class II · Moderate risk
Cephalexin for Oral Suspension
Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk
Doxycycline Hyclate tablets USP
Failed dissolution specifications
Class II · Moderate risk
Doxycycline Hyclate Tablets USP
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class III · Low risk
Cephalexin for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class II · Moderate risk
Altaire Ciprofloxacin HCl Ophthalmic Solution
Lack of Assurance of Sterility
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