Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
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.
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Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
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
Papaverine/Phentolamine/Atropine/PGE-1 Injectable
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
Methylcobalamin 5000 mcg/mL Injectable
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
Papaverine/Phentolamine/PGE-1 Injectable
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
Cyanocobalamin 500 mcg/mL Injectable
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 I · High risk
PYROLA Advanced Joint Formula capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Class II · Moderate risk
OXYCODONE HCl C-II Tablets
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Class II · Moderate risk
NEXIUM¿ (esomeprazole magnesium)
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Class II · Moderate risk
Trypan Blue 0.3%
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Brilliant Blue G BBG
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Human Chorionic Gonadotropic
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
Human Chorionic Gonadotropic
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
METHYLFOLATE Injection
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
METHYLFOLATE Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Liquids
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Lozenges
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
TRI-EST Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Creams
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Suspensions
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Lozenges
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
BI-EST Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin