Cipla Recalls Azacitidine Injection Vials Due to Sterility Concerns
Cipla is recalling 2,151 vials of Azacitidine for Injection due to potential sterility issues caused by improper sealing.
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 sterility defect in an injectable medication, which poses a risk of serious adverse health consequences such as infection.
Plain-English summary
Cipla USA, Inc. is recalling 2,151 vials of Azacitidine for Injection 100 mg/vial. The product is manufactured by Shilpa Medicare Limited in India and distributed nationwide in the United States. The specific lot number is 7S10182A, with an expiration date of September 2021.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the vials may not be sealed correctly, which could affect the sterility of the medication. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected lot of Azacitidine for Injection. Consumers should check their medication for the lot number 7S10182A and expiration date of 9/2021. If the product matches these details, it should be returned to the pharmacy or contact Cipla for further instructions.
The recalled product
- Product
- Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
- Manufacturer
- CIPLA
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 2,151
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 (2)
- Lot #: 7S10182A
- Ex 9/2021
Distribution
Distributed nationwide across the United States.
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