Cipla Recalls Esomeprazole Magnesium Packets Due to Cross-Contamination
Cipla is recalling 284,610 packets of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.
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 severity score under the rubric, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
Cipla USA, Inc. is recalling 284,610 packets of Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg. The product is a prescription-only medication manufactured by Cipla Ltd. in India and distributed nationwide in the United States. The specific lots affected are KA00411, KA00412, and KA00460, all with an expiration date of 11/2021.
The recall was initiated due to cross-contamination with other products. Specifically, the excipient Crospovidone, NF used in the formulation is contaminated with theophylline. This contamination poses a potential risk to patients, particularly those with specific medical conditions or sensitivities to theophylline.
Patients and healthcare providers should discontinue use of the affected lots and return them to the pharmacy or contact Cipla for a replacement or refund. Consumers should check their medication packaging for the lot numbers and expiration dates listed above to determine if their product is affected.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- CIPLA
- Category
- Drug — Prescription Drug
- Affected units
- 284,610
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 (4)
- Lot #: KA00411
- KA00412
- KA00460
- Exp 11/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by CIPLA 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 3 products in this recall →Related recalls
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