Cipla Recalls Esomeprazole Magnesium Suspension Due to Theophylline Contamination
Cipla is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg due to cross-contamination with theophylline in the excipient Crospovidone.
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 for drug recalls involving potential harm.
Plain-English summary
Cipla is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets. The product is a prescription-only medication manufactured by Cipla Ltd. in India for Cipla USA, Inc. The recall involves approximately 289,350 packets distributed nationwide in the United States.
The recall was initiated because the excipient Crospovidone, NF used in the product is contaminated with theophylline. This cross-contamination with another product poses a potential safety risk to patients. The affected lots are KA00413, KA00414, and KA00461, all with an expiration date of 11/2021.
Patients and healthcare providers should check their medication for the specific lot numbers and NDC codes 69097-528-34 or 69097-529-34. If the medication matches the recalled lots, it should not be used. Patients should contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- CIPLA
- Category
- Drug — Prescription Drug
- Affected units
- 289,350
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 #: KA00413
- KA00414
- KA00461
- 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.
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