The Recall Desk
SevereFDA (Drugs)·D-0798-2020·Announced 2020-01-29

RemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination

RemedyRepack Inc. is recalling specific lots of Ranitidine 150 mg tablets because the supplier reported potential Nitrosodimethylamine (NDMA) levels above established limits.

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 potential for significant health risks associated with NDMA contamination.

Plain-English summary

RemedyRepack Inc. is recalling 4,486 tablets of Ranitidine 150 mg. The recall is due to a Current Good Manufacturing Practice (CGMP) deviation and a notice from the supplier indicating potential Nitrosodimethylamine (NDMA) amounts above established levels.

The affected product is identified by Original Supplier's NDC 65162-0253-10 and Remedy Repackaged NDC 70518-1714-00. The specific lots subject to recall are J0376034-052319 (exp. 05/2020), J0406133-093019 (exp. 10/2020), J038005-082719 (exp. 08/2020), J0390280-072519 (exp. 07/2020), J0390277-072519 (exp. 07/2020), and J0349352-012519 (exp. 01/2020).

The product was distributed to two facilities in California and New York. 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 source or disposed of according to local regulations.

The recalled product

Product
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Manufacturer
RemedyRepack Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
4,486

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 (7)

  • Lot #: J0376034-052319
  • exp. date 05/2020 Lot #: J0406133-093019
  • exp. date 10/2020 Lot #: J038005-082719
  • exp. date 08/2020 Lot #: J0390280-072519
  • exp. date 07/2020 Lot #: J0390277-072519
  • exp. date 07/2020 Lot #: J0349352-012519
  • exp. date 01/2020

Distribution

Distributed in 2 states:

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