CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
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Contact the company
📍Recalling firmH J Harkins Company Inc dba Pharma Pac1400 W Grand Ave Ste F · Grover Beach, CA 93433-4221
✎ GovInfoNow plain-language explainer
H J Harkins Company Inc, doing business as Pharma Pac, is recalling a small quantity of Losartan Potassium 100 mg tablets because they contain traces of an impurity called NMBA. The affected product was distributed to a single physician's office in California. The recall addresses current Good Manufacturing Practice (CGMP) deviations regarding the Active Pharmaceutical Ingredient. Read more at govinfonow.com/recall/39133-pharma-pac-recalls-losartan-potassium-100-mg-tablets-due-to.
“Pharma Pac Recalls Losartan Potassium 100 mg Tablets Due to Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39133-pharma-pac-recalls-losartan-potassium-100-mg-tablets-due-to. Based on FDA recall #D-1083-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1083-2019%22&limit=1).
The FDA announced on March 4, 2019, that Pharma Pac recalled Losartan Potassium 100 mg Tablets due to CGMP deviations involving traces of an impurity in the active ingredient. The recall affects 300 tablets distributed to a physician's office in California.
How to tell if you have it
Brand: Pharma Pac
Product: Losartan Potassium 100 mg Tablets # 30
NDC: 76519-1033-03
Lot #: LTO00EW
Expiration: 11/19
MFG NDC: 31722-0702-30
MFG Lot #: LOP17087
MFG Expiration: 11/2019
The hazard
The recall was initiated because traces of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity were found in the Active Pharmaceutical Ingredient. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show H J Harkins Company Inc dba Pharma Pac has issued seven other recalls since July 26, 2018. Other recent recalls of similar products include Appco Pharma Prazosin Capsules Recall: Nitrosamine Impurity Risk (March 27, 2026) and Ajanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk (April 29, 2026).
How to tell if you have this one
Look for white to off-white, film-coated, tear drop shaped tablets debossed with "H" on one side and "145" on the other. Check for Pharma Pac NDC 76519-1033-03 and Lot # LTO00EW with an expiration date of 11/19.
Brand
Pharma Pac
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Your Doctor
If you have taken this medication, speak with your healthcare provider about alternative treatment options or testing.
Return the Medication
Return any remaining tablets from Lot # LTO00EW to the physician's office in California where they were dispensed.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “Product was distributed to a physician's office in California.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 4.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1083-2019 (March 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1083-2019 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.