Shilpa Medicare Recalls Azacitidine Injection Due to Manufacturing Deviations
Shilpa Medicare Limited is voluntarily recalling 35,931 vials of Azacitidine for Injection due to Current Good Manufacturing Practice (CGMP) deviations.
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 source text explicitly states the agency classification is Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe).
Plain-English summary
Shilpa Medicare Limited has initiated a voluntary recall of 35,931 vials of Azacitidine for Injection, 100 mg/vial. The product is a prescription-only cytotoxic agent intended for subcutaneous and intravenous use. The recall was initiated on December 8, 2020, and was classified as Class II by the FDA on December 9, 2020.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots include 7S10115A, 7S10143A, 7S10182B, 7S10255A, 7S10256A, 7S10263A, 7T10028A, and 7T10040A, with expiration dates ranging from July 31, 2021, to January 31, 2022. The product was distributed nationwide in the United States by Armas Pharmaceuticals, Inc.
The recall status is terminated as of March 11, 2022. The FDA classifies this as a Class II recall, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- AZACITIDINE (AZACITIDINE)
- Brand
- AZACITIDINE
- Manufacturer
- Shilpa Medicare Limited
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 35,931
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 (13)
- Lot #s: 7S10115A
- Exp. 07/31/2021
- 7S10143A
- 7S10182B
- Exp. 09/30/2021
- 7S10255A
- 7S10256A
- 7S10263A
- Exp. 11/30/2021
- 7T10028A
- 12/31/2021
- 7T10040A
- Exp. 01/31/2022.
UPCs (1)
- 0372485201013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Shilpa Medicare Limited 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.
See all 6 products in this recall →Related recalls
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