D-0273-2015 Class II Terminated
FDA drug recall D-0273-2015 was initiated by Perry Drug Inc. on November 7, 2014 and is designated Class II. Reason for recall: Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a poten… The recall status is terminated (terminated November 3, 2015). Affected quantity: 20 prefilled syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- December 3, 2014
- Initiation Date
- November 7, 2014
- Termination Date
- November 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 prefilled syringes
Product Description
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
Reason for Recall
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Distribution Pattern
Kansas and Missouri
Code Information
141021FF, 11/21/14; 141028CC, 11/28/14