Dr. Reddy's Recalls ZENATANE Isotretinoin Capsules for Dissolution Failures
Dr. Reddy's Laboratories is recalling ZENATANE (isotretinoin) 20 mg capsules because they failed to meet dissolution specifications. The recall covers 3,858 prescription packs distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling ZENATANE (isotretinoin) 20 mg capsules, 30 capsules per prescription pack. The recall involves 3,858 prescription packs, totaling 115,680 capsules, which were distributed nationwide. The affected product is identified by Lot # 79KB60205 and has an expiration date of 02/18.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate in the body. When this specification is not met, the medication may not work as intended.
Consumers and healthcare providers should stop using the affected ZENATANE capsules and return them to their pharmacy or contact Dr. Reddy's Laboratories for further instructions. This recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- ZENATANE (ISOTRETINOIN)
- Brand
- ZENATANE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
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 # 79KB60205
- Exp. 02/18
Distribution
Distributed nationwide across the United States.
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Same brand · ZENATANE
- ModerateDr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures
FDA (Drugs) · 2017-06-14
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FDA (Drugs) · 2017-06-14
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FDA (Drugs) · 2017-06-14
- ModerateDr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failure
FDA (Drugs) · 2017-06-14
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FDA (Drugs) · 2017-03-08
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