Recalls / Class II
Class IID-0261-2015
Product
Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
- Affected lot / code info
- 141008BB, 11/8/14; 141008CC, 11/8/14; 141010G, 11/10/14; 141010J, 11/10/14; 141010K, 11/10/14; 141013GG, 11/13/14; 141015DD, 11/15/14; 141015BB, 11/15/14; 141020GG, 11/20/14; 141024HH, 11/24/14; 141024II, 11/24/14; 141024JJ, 11/24/14; 141028BB, 11/28/14; 141028CC, 11/28/14; 141031GG, 12/1/14;
Why it was recalled
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.
Recalling firm
- Firm
- Perry Drug Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12200 W 106th St Ste 140, N/A, Overland Park, Kansas 66215-2305
Distribution
- Quantity
- 17 vials
- Distribution pattern
- Kansas and Missouri
Timeline
- Recall initiated
- 2014-11-07
- FDA classified
- 2014-11-24
- Posted by FDA
- 2014-12-03
- Terminated
- 2015-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0261-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.