Prescription-to-Nonprescription (Rx-to-OTC) Switches
A sponsor of a nonprescription drug product may seek to market a prescription drug product as nonprescription.
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FDA Roundup: May 31, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
FDA Roundup: March 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
Drug Alerts and Statements
FDA Drug Alerts and Statements -
Park Avenue Compounding. Saint Louis, MO. 483 issued 09/23/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/23/2025
Short Title (70 char) Park Avenue Compounding. Saint Louis, MO. 483 issued 09/23/2025
FEI Number 1972829
Firm Name Park Avenue Compounding
Record Type 483
State MO
Establishment Type Outsourcing Facil -
Mellace Family Brands California, Inc. Recalls Wegmans Deluxe Mixed Nuts Unsalted, 34 oz and 11.5 oz Packages Because Of Possible Health Risk
Mellace Family Brands California, Inc. of Warren, OH has issued a recall for Wegmans Deluxe Mixed Nuts Unsalted 34 oz Tubs and Wegmans Deluxe Mixed Nuts Unsalted 11.5 oz bags because they have the potential to be contaminated with Salmonella -
FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the pro -
Fromm Family Foods Voluntarily Recalls Bonnihill BeefiBowls Food for Dogs Due to Potential Foreign Material Contamination
MEQUON, WIS. (DECEMBER 3, 2025) – FROMM FAMILY FOODS has issued a recall of 300 cases of Bonnihill Farms BeefiBowls Beef Recipe gently cooked frozen dog food due to potential foreign plastic contamination. -
Correction Alert: Olympus Updates Use Instructions for Ligating Device
Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
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Central Admixture Pharmacy Services Inc. Allentown, PA. 483 issued 09/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) Central Admixture Pharmacy Services Inc. Allentown, PA. 483 issued 09/05/2025
FEI Number 3009590582
Firm Name Central Admixture Pharmacy Services Inc
Record Type 483
State PA
Est -
BlendHouse LLC. Reading, PA. 483 issued 01/19/2024
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 01/19/2024
Short Title (70 char) BlendHouse LLC. Reading, PA. 483 issued 01/19/2024
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type 483
State PA
Establishment Type Manufacturer -
CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)
CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)Draft page