Food, drugs, devices › Preferred Pharmaceuticals, Inc.
Drug recall: Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
FDA enforcement event 90001 is a drug recall by Preferred Pharmaceuticals, Inc. of Anaheim, CA, initiated 12 Apr 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 22 Sep 2022. Initiation: voluntary: firm initiated. Preferred Pharmaceuticals, Inc. has 32 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Preferred Pharmaceuticals, Inc., Anaheim, CA.
Reason for recall
"CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits."
Distribution
"Nationwide within the U.S to CA, IN and FL."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0789-2022 | Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc. | 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets | Class II | Terminated | 4 May 2022 |
Context
Other enforcement events for Preferred Pharmaceuticals, Inc.
All 32 events for Preferred Pharmaceuticals, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the U.S to CA, IN and FL."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Sep 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.