Shilpa Medicare Recalls Discolored Pemetrexed Injection Vials
Shilpa Medicare is recalling 18,434 vials of PEMRYDI RTU (pemetrexed injection) due to reports of green to dark green discoloration in the solution.
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, which corresponds to a Severe rating under the rubric, as it involves a potential for temporary or medically reversible health consequences.
Plain-English summary
Shilpa Medicare Limited is recalling 18,434 vials of PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), single-dose vials. The product is distributed by Amneal Pharmaceuticals LC and is available nationwide in the USA. The recall involves Lot P400172 and Lot PA00050A, with an expiration date of 09/30/2027.
The recall was initiated after the firm received market complaints reporting green to dark green discoloration in certain vials of the solution. This FDA Class II recall indicates that use of the product could cause temporary or medically reversible health consequences.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. The product is a prescription-only intravenous medication.
The recalled product
- Product
- PEMRYDI RTU (PEMETREXED DISODIUM)
- Brand
- PEMRYDI RTU
- Manufacturer
- Shilpa Medicare Limited
- Category
- Drug — Antineoplastic
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 (3)
- Lot: P400172
- Lot PA00050A
- Exp 09/30/2027
UPCs (3)
- 0370121246213
- 0370121246114
- 0370121245315
Distribution
Distributed nationwide across the United States.
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