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