Physicians Total Care Recalls Procrit Injection Due to Glass Delamination
Physicians Total Care is recalling Procrit (epoetin alfa) injection vials because of glass delamination and particulate matter. The recall affects 20 vials distributed in Pennsylvania and California.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (glass delamination) in an injectable drug, which poses a significant risk of injury from particulate matter.
Plain-English summary
Physicians Total Care, Inc. is recalling 20 vials of Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial. The product is manufactured by Amgen Inc. and distributed by Physicians Total Care. The recall is due to the presence of particulate matter caused by glass delamination.
The affected product is identified by NDC 54868-5673-1. Specific lot numbers involved include 44TK, 4NQE, 4WKN, 5KZT, 5RCM, 5RZN, 5Y8Y, and 60E2, with expiration dates ranging from September 2010 to December 2012. The recall is classified as Class II by the FDA.
The product was distributed in Pennsylvania (PA) and California (CA). Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Injectable
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
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