Recalls / Class II
Class IID-0260-2015
Product
Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
- Affected lot / code info
- 141006GG, 11/6/14; 141009FF, 11/9/14; 141014BB, 11/9/14; 141014BB, 11/14/14; 1410164, 11/16/14; 141021GG, 11/21/14; 141030DD, 11/30/14
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
- 186 prefilled syringes
- 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-0260-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.