Cinacalcet 90 mg tablets recalled after failing dissolution specifications
Cinacalcet Tablets 90 mg from Strides Pharma are being recalled because they failed dissolution specifications. 6,672 bottles are affected.
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: FDA Class II recall for an out-of-specification dissolution result, with no health consequence stated in the source.
Plain-English summary
Cinacalcet Tablets, 90 mg, 30-count bottles, prescription only, manufactured by Strides Pharma Science Ltd. of Puducherry, India and distributed by Strides Pharma Inc. of East Brunswick, New Jersey, NDC 64380-885-04, are being recalled. The action covers 6,672 bottles.
The stated reason is failed dissolution specifications. The FDA classified the action as Class II. The source does not state a health consequence.
The affected lot is 7715893A, expiring 12/31/2027. Distribution was nationwide within the United States.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Strides Pharma, Inc.
- Category
- Drug — Oral tablet
- Affected units
- 6,672
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 #: 7715893A
- Exp. Date 12/31/2027
UPCs (3)
- 0364380885047
- 0364380883043
- 0364380884040
Distribution
Distributed nationwide across the United States.
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