Ranitidine 300 mg tablet

Where the pills inside were made

This label doesn't name the factory that makes the drug (it lists 1 site that packages it). Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Amneal Pharmaceuticals names for other drugs.

Repackaging site

• Stat Rx USA, Location not on file · repackages it and relabels it

Recalls

• Nov 22, 2019 · Class II · Amneal Pharmaceuticals, Inc.
  CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
  Lots: HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4…
• Nov 22, 2019 · Class II · Amneal Pharmaceuticals, Inc.
  CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
  Lots: HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB0561…

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Ranitidine: every company that makes it

Form

tablet

Strength

300 mg

Approval

ANDA ANDA077824

On the market since

Dec 16, 2009

Package NDCs

16590-381-30 16590-381-60 16590-381-71

Official label

DailyMed (National Library of Medicine), updated Oct 2, 2012

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