Drug recall: Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy…
Class I FDA enforcement event 90289. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Subpotent drug
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy started this drug recall on 15 Apr 2022. The firm address in the FDA record is in Berkeley, CA. FDA put the recall in Class I. FDA event 90289 has 2 product records. The first FDA enforcement report date is 15 Jun 2022. The record gives the status Terminated, with the termination date 7 Nov 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
CA
Recalling firm
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy, Berkeley, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1167-2022 | Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704, | 1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottles | Class I | Terminated | 15 Jun 2022 |
| D-1168-2022 | Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704 | 950 mLs in 1x8 oz and 2x16 oz bottles. | Class I | Terminated | 15 Jun 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2022
- 325
- Share of these events in Class I
- 18%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jun 2022 | Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704 Event 90539 | Drug | Class I | 1 |
Official channels
- FDA enforcement report D-1167-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90289. https://recallregister.com/fda/i/90289/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
CA
- What quantity of product is in FDA event 90289?
- The event has 2 product records. The first record gives this quantity:
1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2022 have the same class?
- 18% of the 325 drug events that started in 2022 are in Class I.