Dr. Reddy's Recalls Ezetimibe and Simvastatin Tablets Due to Foreign Substance
Dr. Reddy's is recalling specific bottles of Ezetimibe and Simvastatin tablets because black speckles were observed on the tablets.
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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe), even though the specific hazard is a foreign substance.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 1,000-count bottles of Ezetimibe and Simvastatin Tablets 10mg/80 mg. The recall involves Lot # 43E021 and 43E023, which expire in January 2020. The product is distributed nationwide within the United States.
The recall was initiated due to a product complaint regarding the presence of a foreign substance. Specifically, black speckles were observed on the tablets. The agency has classified this recall as Class II.
Consumers who have these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or replacements.
The recalled product
- Product
- Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 118
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 #: 43E021 and 43E023
- Exp. 01/2020
Distribution
Distributed nationwide across the United States.
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