Recalls / Class II
Class IID-093-2013
Product
Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.
- Affected lot / code info
- Lot #: 44TK, Exp 09/10; 4NQE, Exp 05/11; 4WKN, Exp 11/11; 5KZT, 5RCM, Exp 09/12; 5RZN, Exp 10/12; 5Y8Y, 60E2, Exp 12/12
Why it was recalled
Presence of Particulate Matter: glass delamination
Recalling firm
- Firm
- Physicians Total Care, Inc.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 20 vials
- Distribution pattern
- PA, CA
Timeline
- Recall initiated
- 2010-10-04
- FDA classified
- 2012-12-14
- Posted by FDA
- 2012-12-26
- Terminated
- 2013-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-093-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.