US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

NEOstigmine Methylsulfate

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-234-14 D-0702-2018
Class II · Moderate risk Terminated

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile…

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-249-10 D-0701-2018
Class II · Moderate risk Terminated

Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile…

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-127-10 D-0700-2018
Class II · Moderate risk Terminated

Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile…

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-129-10 D-0699-2018
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Out of specification for adhesive transfer.

Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-0627-2018