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Class III: unlikely to cause harmTerminated

Strides Pharma Ndc 64380-721-06 Tacrolimus Capsules Recall

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Str…

Strides Pharma Inc. · East Brunswick, NJ

Risk level
Class III
Reported by FDA
Jan 6, 2021
Recall ID
D-0180-2021
Check your lot numberHow we source this data

Summary

Strides Pharma recalled Ndc 64380-721-06 Tacrolimus Capsules starting Dec 22, 2020. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0180-2021 on Jan 6, 2021. Reason: Failed Moisture Limits. Status: Terminated.

Why it was recalled

Failed Moisture Limits

Product description

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

Lot numbers, UPCs & expiration codes

Lot 7242728A; June 2023

Where it was sold

PA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0180-2021
Classification
Class III
Status
Terminated
Recall initiated
Dec 22, 2020
FDA report date
Jan 6, 2021
Quantity
960 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Strides Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-0180-2021, exactly as published.

Show all FDA fields
City
East Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
87027
Address
2 Tower Center Blvd Ste 1102
Code information
Lot 7242728A; June 2023
Postal code
08816-1100
Report date
Jan 6, 2021
Product type
Drugs
Recall number
D-0180-2021
Classification
Class III
Recalling firm
Strides Pharma Inc.
Product quantity
960 bottles
Termination date
Jan 26, 2022
Reason for recall
Failed Moisture Limits
Voluntary / mandated
Voluntary: Firm initiated
Product description
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Distribution pattern
PA
Recall initiation date
Dec 22, 2020
Initial firm notification
Letter
Center classification date
Dec 30, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0180-2021, published Jan 6, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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