Why it was recalled
Subpotent drug
Product description
Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Lot numbers, UPCs & expiration codes
Lot #: 04272022@35, BUD: 7/7/2022.
Where it was sold
CA
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-1168-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 15, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 950 mLs in 1x8 oz and 2x16 oz bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-1168-2022, exactly as published.
Show all FDA fields
- City
- Berkeley
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90289
- Address
- 2461 Shattuck Ave
- Code information
- Lot #: 04272022@35, BUD: 7/7/2022.
- Postal code
- 94704
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-1168-2022
- Classification
- Class I
- Recalling firm
- Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
- Product quantity
- 950 mLs in 1x8 oz and 2x16 oz bottles.
- Termination date
- Nov 7, 2022
- Reason for recall
- Subpotent drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
- Distribution pattern
- CA
- Recall initiation date
- Apr 15, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 27, 2022