Why it was recalled
Presence of Particulate Matter: glass delamination
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
PA, CA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-093-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 4, 2010
- FDA report date
- Dec 26, 2012
- Quantity
- 20 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-093-2013, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 63841
- Address
- 12515 E 55th St Ste 100
- Code information
- 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
- Postal code
- 74146-6234
- Report date
- Dec 26, 2012
- Product type
- Drugs
- Recall number
- D-093-2013
- Classification
- Class II
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 20 vials
- Termination date
- May 7, 2013
- Reason for recall
- Presence of Particulate Matter: glass delamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- PA, CA
- Recall initiation date
- Oct 4, 2010
- Initial firm notification
- FAX
- Center classification date
- Dec 14, 2012