Strides Pharma Recalls Cinacalcet Tablets for Failed Dissolution Specifications
Strides Pharma Inc. is recalling 49,488 bottles of Cinacalcet Tablets, 30 mg, because they failed dissolution specifications. The recall is classified as Class II.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to failed dissolution specifications, which may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Strides Pharma Inc. is recalling 49,488 30-count bottles of Cinacalcet Tablets, 30 mg, prescription only. The product is identified by Lot # 7717825A and has an expiry date of 11/30/2028. The recall was initiated because the tablets failed to meet dissolution specifications.
The affected product was distributed nationwide in the United States. The tablets are manufactured by Strides Pharma Science Ltd. in India and distributed by Strides Pharma Inc. in Bridgewater, NJ. The NDC for the recalled product is 64380-883-04.
The FDA has classified this recall as Class II, which indicates that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- STRIDES PHARMA 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 # 7717825A
- Expiry: 11/30/2028.
UPCs (3)
- 0364380885047
- 0364380883043
- 0364380884040
Distribution
Distributed nationwide across the United States.
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