Strides Pharma Recalls Tacrolimus Capsules for Failed Moisture Limits
Strides Pharma Inc. is recalling 960 bottles of 1mg Tacrolimus capsules due to failed moisture limits. The recall is limited to Pennsylvania.
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 agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor quality issues.
Plain-English summary
Strides Pharma Inc. is recalling 960 bottles of TACROLIMUS CAPSULES, USP 1mg (NDC 64380-721-06). The product is manufactured by Strides Pharma Science Ltd. in Bengaluru, India, and distributed by Strides Pharma Inc. in East Brunswick, NJ. The specific lot affected is 7242728A, with a June 2023 expiration date.
The recall was initiated because the product failed moisture limits. This is a Class III recall, which indicates that the violation is not likely to cause adverse health consequences. The distribution was limited to Pennsylvania (PA).
Consumers who have this specific lot of medication should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Strides Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 960
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 7242728A
- June 2023
UPCs (3)
- 0364380721062
- 0364380720065
- 0364380722069
Distribution
Distributed in 1 state:
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