The Recall Desk
SevereFDA (Drugs)·D-1083-2019·Announced 2019-04-17

Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity

Pharma Pac is recalling Losartan Potassium 100 mg tablets because traces of a nitrosamine impurity were found in the active ingredient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the presence of a nitrosamine impurity which is a potential carcinogen.

Plain-English summary

H J Harkins Company Inc dba Pharma Pac is recalling Losartan Potassium 100 mg tablets. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) impurity in the Active Pharmaceutical Ingredient (API).

The affected product consists of white to off-white, film-coated, tear-drop shaped tablets debossed with "H" on one side and "145" on the other. The specific lot numbers involved are Pharma Pac Lot # LTO00EW (Exp. 11/19) and MFG Lot # LOP17087 (Exp. 11/2019). The NDC numbers are 76519-1033-03 and 31722-0702-30.

The product was distributed to a physician's office in California. Patients who have received this medication should consult their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
Manufacturer
H J Harkins Company Inc dba Pharma Pac
Category
Drug — Prescription Medication
Hazard
Affected units
300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Pharma Pac NDC: 76519-1033-03
  • Pharma Pac Lot # LTO00EW
  • Exp. 11/19
  • MFG NDC 31722-0702-30
  • MFG Lot # LOP17087
  • Exp. 11/2019.

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · H J Harkins Company Inc dba Pharma Pac

See all →

Same hazard · nitrosamine impurity

See all →