Recall Enforment Report D-0613-2020

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amneal Pharmaceuticals, Inc., originally initiated on 11-22-2019 for the product Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25). The product was recalled due to cgmp deviations: impurity n-nitrosodimethylamine (ndma) found in api. The product was distributed in Product Was Distributed Throughout The United States. and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0613-2020	11-22-2019	12-18-2019	Class II	N/A	Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Ongoing
D-0616-2020	11-22-2019	12-18-2019	Class II	N/A	Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Ongoing
D-0612-2020	11-22-2019	12-18-2019	Class II	N/A	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).	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Ongoing
D-0615-2020	11-22-2019	12-18-2019	Class II	N/A	Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Ongoing
D-0614-2020	11-22-2019	12-18-2019	Class II	N/A	Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
53746-253	Ranitidine	Ranitidine	Tablet	Oral	Amneal Pharmaceuticals Of New York Llc	Human Prescription Drug
53746-254	Ranitidine	Ranitidine	Tablet	Oral	Amneal Pharmaceuticals Of New York Llc	Human Prescription Drug
65162-253	Ranitidine	Ranitidine	Tablet	Oral	Amneal Pharmaceuticals Llc	Human Prescription Drug
65162-254	Ranitidine	Ranitidine	Tablet	Oral	Amneal Pharmaceuticals Llc	Human Prescription Drug

Field Name	Field Value
Event ID	84353 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0613-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed throughout the United States. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Reason For Recall	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	12-18-2019
Recall Initiation Date	11-22-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amneal Pharmaceuticals, Inc.
Code Info	AR172033B 11/2019 AR180024A 12/2019 AR180025A 12/2019 AR180118A 12/2019 AR180119A 12/2019 AR180519A 3/2020 AR180615A 3/2020 AR181795A 11/2020 AR181921B 12/2020 AR190705A 4/2021 AR172029A 11/2019 AR172030A 11/2019 AR180021A 12/2019 AR180022A 12/2019 AR180023A 12/2019 AR180123A 12/2019 AR180144A 1/2020 AR180145A 1/2020 AR180146A 1/2020 AR180147A 1/2020 AR180402A 2/2020 AR180465A 2/2020 AR180466A 2/2020 AR180467A 2/2020 AR180468A 2/2020 AR180613A 3/2020 AR181156A 7/2020 AR181157A 7/2020 AR190418B 2/2021 AR171800A 11/2019 AR171801A 11/2019 AR171802A 11/2019 AR171803A 11/2019 AR171804A 11/2019 AR171931A 11/2019 AR171932A 11/2019 AR171933A 11/2019 AR171934A 11/2019 AR171935A 11/2019 AR171936A 11/2019 AR171937A 11/2019 AR172026A 11/2019 AR172027A 11/2019 AR172028A 11/2019 AR172031A 11/2019 AR172032A 11/2019 AR172033A 11/2019 AR172034A 11/2019 AR172035A 11/2019 AR180030A 12/2019 AR180031A 12/2019 AR180032A 12/2019 AR180033A 12/2019 AR180034A 12/2019 AR180113A 12/2019 AR180114A 12/2019 AR180115A 12/2019 AR180117A 12/2019 AR180120A 12/2019 AR180121A 12/2019 AR180122A 12/2019 AR180148A 1/2020 AR180198A 1/2020 AR180199A 1/2020 AR180200A 1/2020 AR180201A 1/2020 AR180202A 1/2020 AR180257A 1/2020 AR180258A 1/2020 AR180335A 2/2020 AR180336A 2/2020 AR180337A 2/2020 AR180338A 2/2020 AR180339A 2/2020 AR180374A 2/2020 AR180375A 2/2020 AR180376B 2/2020 AR180403A 2/2020 AR180404A 2/2020 AR180405A 2/2020 AR180406A 2/2020 AR180424A 2/2020 AR180486A 3/2020 AR180487A 3/2020 AR180488A 3/2020 AR180515A 3/2020 AR180516A 3/2020 AR180517A 3/2020 AR180518A 3/2020 AR180638A 3/2020 AR180640A 4/2020 AR180641A 4/2020 AR181920A 12/2020 AR181921A 12/2020 AR190414B 2/2021 AR190415A 2/2021 AR190416A 2/2021 AR190417A 2/2021 AR190418A 2/2021 AR190543A 3/2021 AR190544A 3/2021 AR190545A 3/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	65162-253-06; 65162-253-10; 65162-253-18; 65162-253-50; 65162-253-11; 65162-254-03; 65162-254-10; 65162-254-25; 65162-254-11; 65162-254-30
Status	Ongoing

Field Name	Field Value
Event ID	84353 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0616-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed throughout the United States. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Reason For Recall	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	12-18-2019
Recall Initiation Date	11-22-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amneal Pharmaceuticals, Inc.
Code Info	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 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	53746-253-60; 53746-253-01; 53746-253-18; 53746-253-05; 53746-253-10; 53746-254-30; 53746-254-01; 53746-254-02
Status	Ongoing

Field Name	Field Value
Event ID	84353 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0612-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed throughout the United States. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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).
Reason For Recall	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	12-18-2019
Recall Initiation Date	11-22-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amneal Pharmaceuticals, Inc.
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	65162-253-06; 65162-253-10; 65162-253-18; 65162-253-50; 65162-253-11; 65162-254-03; 65162-254-10; 65162-254-25; 65162-254-11
Status	Ongoing

Field Name	Field Value
Event ID	84353 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0615-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed throughout the United States. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Reason For Recall	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	12-18-2019
Recall Initiation Date	11-22-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amneal Pharmaceuticals, Inc.
Code Info	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 4/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	53746-253-60; 53746-253-01; 53746-253-18; 53746-253-05; 53746-253-10; 53746-254-30; 53746-254-01; 53746-254-02
Status	Ongoing

Field Name	Field Value
Event ID	84353 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0614-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Product was distributed throughout the United States. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Reason For Recall	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	12-18-2019
Recall Initiation Date	11-22-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amneal Pharmaceuticals, Inc.
Code Info	06648001A 11/2019 06648003A 4/2020 06649001A 1/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Ongoing