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Class II: temporary or reversible health riskTerminated

Preferred Pharmaceuticals Losartan Potassium & HCTZ Tablets 50mg/12 Recall

Losartan Potassium & HCTZ Tablets 50mg/12

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Risk level
Class II
Reported by FDA
Jun 1, 2022
Recall ID
D-0892-2022
Check your lot numberHow we source this data

Summary

Preferred Pharmaceuticals recalled Losartan Potassium & HCTZ Tablets 50mg/12 starting May 3, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0892-2022 on Jun 1, 2022. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Status: Terminated.

Why it was recalled

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Product description

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.

Lot numbers, UPCs & expiration codes

Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.

Where it was sold

Within the U.S in FL and 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-0892-2022
Classification
Class II
Status
Terminated
Recall initiated
May 3, 2022
FDA report date
Jun 1, 2022
Quantity
47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
Recall type
Voluntary: Firm initiated
Recalling firm
Preferred Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0892-2022, exactly as published.

Show all FDA fields
City
Anaheim
State
CA
Status
Terminated
Country
United States
Event ID
90148
Address
1250 N Lakeview Ave Ste O
Code information
Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.
Postal code
92807-1801
Report date
Jun 1, 2022
Product type
Drugs
Recall number
D-0892-2022
Classification
Class II
Recalling firm
Preferred Pharmaceuticals, Inc.
Product quantity
47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
Termination date
Sep 21, 2022
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Voluntary / mandated
Voluntary: Firm initiated
Product description
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Distribution pattern
Within the U.S in FL and CA.
Recall initiation date
May 3, 2022
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 24, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0892-2022, published Jun 1, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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