drugs MODERATE Updated 2019-10-16

Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules R

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Recalled Product

Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

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Hazard / Issue

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall