The Recall Desk
SevereFDA (Drugs)·D-0341-2021·Announced 2021-05-05

PD-Rx Recalls Losartan Potassium Tablets Due to Trace NMBA Contamination

PD-Rx Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because they contain trace amounts of NMBA, a potential carcinogen.

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, and the presence of NMBA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 576 bottles of Losartan Potassium USP, 50 mg tablets. The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation where the product was found to contain trace amounts of N-methyl-N-nitrosobutylamine (NMBA). NMBA is a potential carcinogen that is not permitted in pharmaceutical products.

The affected product is distributed in Alaska, Arizona, California, Colorado, Florida, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Ohio, Oregon, Wisconsin, and Wyoming. The recall includes specific lot numbers with expiration dates ranging from September 30, 2019, to November 30, 2019. The NDC numbers for the affected packages are 43063-854-60 and 43063-0854-90.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for disposal. Patients should consult their healthcare provider for alternative treatment options if they have been taking the affected medication.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
576

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 (15)

  • Lots: A19B99 Exp. 11/30/2019
  • B19A26 Exp. 11/30/2019
  • B19A69 Exp. 11/30/2019
  • E18F12 Exp.: 09/30/19
  • F18A12 Exp.: 09/30/19
  • F18F06 Exp.: 09/30/19
  • G18B43 Exp.: 09/30/19
  • G18C43 Exp.: 09/30/19
  • G18F75 Exp.: 09/30/19
  • H18D55 Exp.: 09/30/19
  • I18A11 Exp.: 09/30/19
  • I18E32 Exp.: 09/30/19
  • J18A90 Exp.: 09/30/19
  • J18D50 Exp. 11/30/2019
  • L18D01 Exp. 11/30/2019

UPCs (1)

  • 0343063854907

Distribution

Distributed in 14 states:

Related recalls

Same brand · LOSARTAN POTASSIUM

Same manufacturer · PD-Rx Pharmaceuticals, Inc.

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