Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 246
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Summary
The FDA issued a Class I for Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medi by Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy. Reason: Subpotent drug.
Details
Source
Drug Recall
External ID
D-1168-2022
Action Date
2022-06-15
Status
Terminated
Category
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/Code Info: Lot #: 04272022@35, BUD: 7/7/2022.
Quantity Affected: 950 mLs in 1x8 oz and 2x16 oz bottles.
Reason for Recall
Subpotent drug
Distribution
CA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-15
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 180 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy have FDA actions?
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1168-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22