Drug product
Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
D-0263-2015
Product summary
- Firm
- Perry Drug Inc.
- Event
- Event 69674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 prefilled syringes
- Official record key
drug-enforcement:D-0263-2015
Official wording
Reason: 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.
Code information: 141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14
Distribution pattern: Kansas and Missouri
Derived failure modes
-
Sterility assurance
Lack of sterility