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# FDA Orders Recall of Sterile Drug at Compounder
- URL: https://www.fdaweb.com/fda-orders-recall-of-sterile-drug-at-compounder/
- Published: 2016-05-05T12:00:00.000Z
- Updated: 2026-09-14T21:00:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135588

FDA has ordered drug compounder Medaus (Birmingham, AL) to conduct an immediate recall of all sterile drug products based on GMP deficiencies documented during a recent inspection. The just-posted agency [recall letter](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm499328.pdf?ref=fdaweb.com) says the March inspection observed “insanitary conditions including poor aseptic production practices” that resulted in a lack of sterility assurance. For example, the agency says that supplies and materials moved into the critical ISO 5 zone from a less critical ISO 5 zone without any decontaminating step. “This practice increases the risk of introduction of microbial contamination into the ISO 5 area,” it says.