Ascend Recalls Olmesartan Medoxomil Tablets Due to cGMP Deviations
Ascend Laboratories is recalling 192 bottles of Olmesartan Medoxomil 20 mg tablets because they were released in error with an alternate API source before approval.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific adverse events are mentioned in the source text.
Plain-English summary
Ascend Laboratories LLC is recalling 192 bottles of Olmesartan Medoxomil Tablets 20 mg, NDC 67877-446-90. The product is a prescription-only medication distributed nationwide in the U.S. The specific lot number is 19122552, with an expiration date of 7/31/2021.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. The source text states that the tablets were released in error with an alternate active pharmaceutical ingredient (API) source prior to the filing and approval of a Prior Approval Supplement.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II.
The recalled product
- Product
- OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
- Brand
- OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Prescription Drug
- Affected units
- 192
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 #: 19122552
- Exp 7/31/2021
UPCs (1)
- 0367877445304
Distribution
Distributed nationwide across the United States.
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