Multi-event March 2020 FDA Recall Mirtazapine by Aurobindo Pharma Usa Inc.
This Multi-event Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on March 18, 2020 for the product Mirtazapine. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-1236-2020 D-1233-2020 D-1234-2020 D-1232-2020 D-1235-2020 D-1231-2020 D-1230-2020 D-1237-2020 D-1229-2020
Recall Number: D-1236-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
2101 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
Batch or Lot Expiration Information
Lot# : 105180004A, Exp. Date 03/2020
Affected Packages Involved in this Recall
Recall Number: D-1233-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
8040 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
Batch or Lot Expiration Information
Lot# : 24719001A1, Exp. Date 03/2021
Recall Number: D-1234-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
26976 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Batch or Lot Expiration Information
Lot# : 05319004A1, Exp. Date 03/2022
Affected Packages Involved in this Recall
Recall Number: D-1232-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
26625 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Batch or Lot Expiration Information
Lot# : 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021
Affected Packages Involved in this Recall
Recall Number: D-1235-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
56208 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Batch or Lot Expiration Information
Lot# : 031180028A, Exp. Date 03/2021
Affected Packages Involved in this Recall
Recall Number: D-1231-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
57337 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Batch or Lot Expiration Information
Lot# : 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
Affected Packages Involved in this Recall
Recall Number: D-1230-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
4332 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Batch or Lot Expiration Information
Lot# : 059180023A, 059180024A and 059180025A, Exp. Date 05/2021
Affected Packages Involved in this Recall
Recall Number: D-1237-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
14707 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Batch or Lot Expiration Information
Lot# : 046180056A, Exp. Date 05/2020
Affected Packages Involved in this Recall
Recall Number: D-1229-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
03-18-2020
04-22-2020
14194 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
03-25-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Batch or Lot Expiration Information
Lot# : 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021
