Mylan Recalls Gemcitabine Injection Vials Due to Particulate Matter
Mylan Institutional LLC is recalling specific lots of Gemcitabine for Injection due to the presence of particulate matter. The affected vials were distributed nationwide and in Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Mylan Institutional LLC is recalling specific lots of Gemcitabine for Injection, USP, 200 mg/vial. The recall is being conducted because of the presence of particulate matter in the lyophilized powder. The product is a prescription-only medication manufactured in India and distributed by Pfizer Labs.
The recall affects two specific NDC codes: 67457-464-20 (manufactured for Mylan Institutional LLC) and 0069-3857-10 (distributed by Pfizer Labs). The affected lots include 7801396, 7801398, 7801401, 7801406, 7801427, 7801089, and 7801110. The total quantity involved is 35,197 vials for the Mylan-labeled product and 21,302 vials for the Pfizer-distributed product.
These products were distributed nationwide and in Puerto Rico. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfize
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Antineoplastic
- Hazard
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 (12)
- Lot #: a) 7801396
- 7801398
- 7801401
- 7801406
- Exp 08/16
- 7801427
- Exp 09/16
- b) 7801089
- 7801084
- Exp 07/15
- 7801110
- Exp 08/15
Distribution
Part of a larger recall action
This product is one of 3 recalled by Mylan Institutional LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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