The Recall Desk
SevereFDA (Drugs)·D-0524-2020·Announced 2019-12-04

AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

AVKARE Inc. is recalling specific lots of Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

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' rating under the rubric for significant potential health risks such as impurity contamination.

Plain-English summary

AVKARE Inc. is recalling specific lots of AVKARE Ranitidine Tablets, USP 150 mg. The recall was initiated because Current Good Manufacturing Practice (CGMP) deviations were identified, specifically the presence of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).

The affected products are prescription-only tablets manufactured for AVKARE, Inc. by Amneal Pharmaceuticals of NY. The recall covers 631,138 bottles distributed nationwide in three package sizes: 1000 tablets (NDC 42291-724-10), 180 tablets (NDC 42291-724-18), and 60 tablets (NDC 42291-724-60). Specific lot numbers and expiration dates are listed in the official recall notice.

Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed in the recall. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for a refund or replacement.

The recalled product

Product
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
631,138

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 (20)

  • Lots: a) HK16617A Exp. 11/30/2019
  • HL03917A Exp. 11/30/2019
  • HL04017A Exp. 11/30/2019
  • HM06017A Exp. 11/30/2019
  • HM06117A Exp. 11/30/2019
  • HB03518A Exp. 03/31/2020
  • HB03618A Exp. 03/31/2020
  • HC14018A Exp. 04/30/2020
  • HC14118A Exp. 04/30/2020
  • HC14218A Exp. 04/30/2020
  • HC14318A Exp. 04/30/2020
  • HC14418A Exp. 04/30/2020
  • HC14518A Exp. 05/31/2020
  • HH04518A Exp. 08/31/2020
  • HH04618A Exp. 08/31/2020
  • HH04718A Exp. 08/31/2020
  • HH04818A Exp. 08/31/2020
  • HH04918A Exp. 08/31/2020
  • HK02718A Exp. 10/31/2020
  • HK06918A Exp. 10/31/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · AVKARE Inc.

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Same hazard · ndma impurity

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