FDA Recall D-0612-2020

Amneal Pharmaceuticals, Inc. · Brookhaven, NY

Class II Ongoing 2365 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

Lot / code: AR171764A 11/2019 AR171875A 11/2019 AR171876A 11/2019 AR171981A 11/2019 AR180020C 1/2020 AR180206A 1/2020 AR180207A 1/2020 AR180208A 1/2020 AR180438A 2/2020 AR180439A 2/2020 AR180481A 3/2020 AR180482A 3/2020 AR180483A 3/2020 AR181690A 10/2020 AR181691A 10/2020 AR181806A 11/2020 AR190058A 12/2020 AR190059A 12/2020 AR190183A 1/2021 AR190184A 1/2021 AR171984A 12/2019 AR180020B 1/2020 AR180675A 4/2020 AR180868B 5/2020 AR181807A 11/2020 AR190366B 2/2021 AR171986A 12/2019 AR171987A 12/2019 AR180255A 1/2020 AR180441A 2/2020 AR180442A 2/2020 AR180559A 3/2020 AR180560A 3/2020 AR180594A 3/2020 AR180595A 3/2020 AR180829A 4/2020 AR180831A 5/2020 AR180832A 5/2020 AR180868A 5/2020 AR181807C 11/2020 AR190085A 12/2020 AR190086A 12/2020 AR190087A 12/2020 AR190124A 1/2021 AR190542B 3/2021 AR190609A 3/2021 AR190610A 3/2021 AR171875B 11/2019 AR180483B 3/2020 AR181807B 11/2020 AR190008B 12/2020 AR171763A 11/2019 AR171764B 11/2019 AR171874A 11/2019 AR171875C 11/2019 AR171877B 11/2019 AR171878B 11/2019 AR171982A 11/2019 AR171983A 12/2019 AR171985A 12/2019 AR180016A 12/2019 AR180017A 12/2019 AR180018A 12/2019 AR180019A 12/2019 AR180020A 1/2020 AR180208B 1/2020 AR180256A 1/2020 AR180291A 1/2020 AR180292A 1/2020 AR180293A 1/2020 AR180294A 2/2020 AR180295A 2/2020 AR180364A 2/2020 AR180365A 2/2020 AR180366A 2/2020 AR180367A 2/2020 AR180368A 2/2020 AR180440B 2/2020 AR180484A 3/2020 AR180485A 3/2020 AR180556A 3/2020 AR180557A 3/2020 AR180558A 3/2020 AR180596A 3/2020 AR180597A 3/2020 AR180598A 3/2020 AR180599A 3/2020 AR180675B 4/2020 AR180676A 4/2020 AR180677A 4/2020 AR180678A 4/2020 AR180679A 4/2020 AR180801A 4/2020 AR180802A 4/2020 AR180803A 4/2020 AR180869A 5/2020 AR180870A 5/2020 AR180871A 5/2020 AR180872A 5/2020 AR180994A 5/2020 AR180995A 5/2020 AR180996A 5/2020 AR180997A 6/2020 AR180998A 6/2020 AR181158A 7/2020 AR181159A 7/2020 AR181160A 7/2020 AR181161A 7/2020 AR181692A 10/2020 AR181693A 10/2020 AR181694A 10/2020 AR181709A 10/2020 AR181710A 11/2020 AR181711A 11/2020 AR181808A 11/2020 AR181809A 11/2020 AR190004A 12/2020 AR190005A 12/2020 AR190006A 12/2020 AR190007A 12/2020 AR190008A 12/2020 AR190088A 12/2020 AR190089A 12/2020 AR190090A 12/2020 AR190121A 12/2020 AR190122A 12/2020 AR190123A 12/2020 AR190125B 1/2021 AR190181A 1/2021 AR190182A 1/2021 AR190364A 2/2021 AR190365A 2/2021 AR190366A 2/2021 AR190509A 3/2021 AR190510A 3/2021

Quantity: N/A

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Recall record

Recall number: D-0612-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed throughout the United States.
Recall initiated: 2019-11-22
Classified by FDA Center: 2019-12-09
FDA published: 2019-12-18
Recalling firm: Amneal Pharmaceuticals, Inc.
Firm location: Brookhaven, NY

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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