Multi-event February 2018 FDA Recall Drug by American Pharmaceutical Ingredients Llc

This Multi-event Class II drug recall was voluntarily initiated by American Pharmaceutical Ingredients Llc on February 9, 2018 for the product Drug. 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-0481-2018 TERMINATED D-0498-2018 TERMINATED D-0480-2018 TERMINATED D-0509-2018 TERMINATED D-0511-2018 TERMINATED D-0533-2018 TERMINATED D-0525-2018 TERMINATED D-0482-2018 TERMINATED D-0496-2018 TERMINATED D-0500-2018 TERMINATED D-0513-2018 TERMINATED D-0489-2018 TERMINATED D-0523-2018 TERMINATED D-0512-2018 TERMINATED D-0494-2018 TERMINATED D-0493-2018 TERMINATED D-0474-2018 TERMINATED D-0526-2018 TERMINATED D-0524-2018 TERMINATED D-0515-2018 TERMINATED D-0529-2018 TERMINATED D-0516-2018 TERMINATED D-0520-2018 TERMINATED D-0522-2018 TERMINATED D-0484-2018 TERMINATED D-0479-2018 TERMINATED D-0504-2018 TERMINATED D-0539-2018 TERMINATED D-0475-2018 TERMINATED D-0506-2018 TERMINATED D-0535-2018 TERMINATED D-0503-2018 TERMINATED D-0532-2018 TERMINATED D-0527-2018 TERMINATED D-0485-2018 TERMINATED D-0477-2018 TERMINATED D-0476-2018 TERMINATED D-0483-2018 TERMINATED D-0538-2018 TERMINATED D-0501-2018 TERMINATED D-0495-2018 TERMINATED D-0531-2018 TERMINATED D-0528-2018 TERMINATED D-0490-2018 TERMINATED D-0518-2018 TERMINATED D-0488-2018 TERMINATED D-0487-2018 TERMINATED D-0517-2018 TERMINATED D-0534-2018 TERMINATED D-0499-2018 TERMINATED D-0537-2018 TERMINATED D-0478-2018 TERMINATED D-0519-2018 TERMINATED D-0514-2018 TERMINATED D-0492-2018 TERMINATED D-0536-2018 TERMINATED D-0497-2018 TERMINATED D-0521-2018 TERMINATED D-0510-2018 TERMINATED D-0508-2018 TERMINATED D-0502-2018 TERMINATED D-0486-2018 TERMINATED D-0530-2018 TERMINATED D-0505-2018 TERMINATED D-0491-2018 TERMINATED D-0507-2018 TERMINATED

Recall Number: D-0481-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
123900 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020

Recall Number: D-0498-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
191000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 102015-3, Exp. 07/31/2020; 081616-3R, Exp. 02/28/2021; b) 081616-3, 081616-3R, Exp. 02/28/2021; 102015-2, Exp. 07/31/2020; c) 081616-1R, Exp. 02/28/2021; 081616-1, Exp. 02/29/2021; 102015-1, 102015-2, Exp. 07/31/2020; d) 102015-1, Exp. 07/31/2020; 081616-1, Exp. 02/29/2021; 081616-1R, 081616-2R, Exp. 02/28/2021.

Recall Number: D-0480-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
5000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 070915-1, Exp. 12/31/2019; b) 070915-1, Exp. 12/31/2019; c) 070915-1, Exp. 12/31/2019; d) 070915-1, Exp. 12/31/2019

Recall Number: D-0509-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
73 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.

Batch or Lot Expiration Information

Lot# : 090517A-1, Exp. 09/13/2018

Recall Number: D-0511-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
7000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 120916-1, Exp. 10/31/2019; b) 120916-1, Exp. 10/31/2019 c) 120916-1, Exp. 10/31/2019; d) 120916-1, Exp. 10/31/2019.

Recall Number: D-0533-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 070717-2, Exp. 05/31/2020; b) 070717-1, Exp. 05/31/2020; c) 070717-1, Exp. 05/31/2020; d) 070717-1, Exp. 05/31/2020.

Recall Number: D-0525-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
33000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 071516-3, Exp. 04/01/2019; b) 071516-3, Exp. 4/1/2019; c) 071516-1, 071516-2, Exp. 04/01/2019; d) 071516-1, 071516-3, Exp. 04/01/2019, 032117B-1, Exp. 2/9/2020.

Recall Number: D-0482-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
13335 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 062515-2, Exp. 02/28/2019; b) 062515-1, Exp. 02/28/2019; 062515-2, Exp. 02/28/2019; 052317B-2, Exp. 01/31/2021; c) 052317B-1, Exp. 01/31/2021; 052317B-1, Exp. 01/31/2021; 062515-1, exp. 02/28/2019; d) 052317B-1, Exp. 01/31/2021; 062515-3, exp. 02/28/2019.

Recall Number: D-0496-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
1638 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 012016-2, Exp. 11/30/2020; b) 012016-1, Exp. 11/30/2020; c) 012016-1, Exp. 11/30/2020; 012016-2, Exp.11/30/2020

Recall Number: D-0500-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
225300 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 051916-1, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018; 041216-2, Exp. 03/27/2019; b) 051916-1, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; c) 041216-1, Exp. 03/27/2019; 051916-3, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; d) 041216-1, 041216-3, Exp. 03/27/2019; 051916-2, 051916-3, 051916-4, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018

Recall Number: D-0513-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
44500 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 020615-2, Exp. 12/04/2018; b) 020615-2, Exp. 12/04/2018; c) 020615-1, Exp. 12/04/2018; d) 020615-1, Exp. 12/04/2018; 020615-2, Exp. 12/04/2018.

Recall Number: D-0489-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
4910 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# Lot: #:a) 083017-1, Exp. 7/22/2022; b) 083017-1, Exp. 7/22/2022; c) 083017-1, Exp. 7/22/2022.

Recall Number: D-0523-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
75 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 053116-1R, Exp.04/30/2018; b) 053116-1R, Exp.04/30/2018

Recall Number: D-0512-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
86225 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 012716-1, 012716-2, Exp. 01/12/2019; 110316-3, Exp. 09/21/2021 b) 012716-1, 012716-3, Exp. 01/12/2019; 110316-1, 110316-3, Exp. 09/21/2021; c) 012716-1, 012716-3, Exp. 01/12/2019; 110316-1, 110316-2, Exp. 09/21/2021; exp. 09/21/2021; d) 012716-1, 012716-3, Exp. 01/12/2019; 041717-2, Exp. 04/06/2022; 110316-1, 110316-2, Exp. 09/21/2021.

Recall Number: D-0494-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
606950

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 031116-7, exp. 03/31/2019; 112816-1, Exp. 03/01/2020 b) 011717-2, 051617-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-7, exp. 03/31/2019; 051215-1, exp. 03/05/2018; 063015-1, Exp. 05/19/2018; 092315-1, Exp. 07/17/2018; 111615-6, Exp. 08/27/2018; 112816-1, Exp. 03/01/2020; c) 011717-7, 011717-2, 051617-1, 082117B-1, Exp. 04/30/2020; ; 031116-2, 031116-4, 031116-5, 031116-7, Exp.. 03/31/2019; 051215-1, Exp. 03/05/2018; 092315-2, Exp. 07/17/2018; 111615-4, 111615-5, Exp. 08/27/2018; 112816-1, 112816-2, Exp. 03/01/2020; d) 011717-7, 051617-1, 082117B-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-3, 031116-4, 031116-6, 031116-7, Exp. 03/31/2019; 051215-1, 051215-3, Exp. 03/05/2018; 063015-2, Exp. 05/19/2018; 111615-1, 111615-2, 111615-3, Exp. 08/27/2018; 112816-2, Exp. 03/01/2020

Recall Number: D-0493-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
193000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 062915-2, Exp. 04/30/2020; b) 022416-1, Exp. 11/30/2020; 062915-2, exp. 04/30/2020; 081215-2, Exp. 06/30/2020; c) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; d) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; 110415-1, Exp. 09/30/20120

Recall Number: D-0474-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
15000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

Batch or Lot Expiration Information

Lot# : a) 031915-1, Exp. 12/31/2019; b) 031915-2, Exp. 12/31/2019; c) 031915-2, Exp. 12/31/2019; d) 031915-1, Exp. 12/31/2019.

Recall Number: D-0526-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
611400 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 032117A-6, Exp. 01/21/2019; 112916-2, 112916-4, Exp. 10/17/2018; b) 032117A-4, 032117A-5, Exp. 01/21/2019; 112916-1, Exp. 10/17/2018; 112916-4, Exp. 10/17/2018; c) 032117A-1, 032117A-2, 032117A-3, 032117A-4, 032117A-5, Exp. 01/21/2019; 112916-1, 112916-2, 112916-3, 112916-4, Exp. 10/17/2018.

Recall Number: D-0524-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
90000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 020717-3, Exp. 12/31/2021; b) 020717-2 020717-4, 020717-5 Exp. 12/31/2021; 092816-2, 092816-3, Exp. 07/31/2021; 121015-4, 121015-5, 121015-6, Exp.10/31/2020; c) 020717-1, 020717-4, 020717-5, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 092816-2, Exp. 07/31/2021; 121015-1,121015-3, Exp. 10/31/2020; d) 020717-1, 020717-2, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 121015-2, Exp. 10/31/2020; e) 020717-1,020717-2 Exp. 12/31/2021.

Recall Number: D-0515-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
29550 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 092515-1, Exp. 5/31/2020; b) 092515-1, Exp. 5/31/2020.

Recall Number: D-0529-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
63975 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) UT2140602-1132014, Exp. 05/31/2019; b) UT2140602-1142014, UT2140602-4222015, Exp. 05/31/2019; UT2140602-10292014, Exp. 05/31/02019; UT2131205UI-1192015, Exp.11/30/2018; UT2140602-10292014, Exp. 05/31/2019; c) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, Exp. 11/30/2018; UT2140602-4222015, Exp. 5/31/2019; d) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, UT2131205UI-1192015, Exp. 11/30/2018.

Recall Number: D-0516-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
6000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 080315-1, Exp. 04/05/2018; b) 080315-1, Exp. 04/05/2018, c) 080315-1, Exp. 04/05/2018.

Recall Number: D-0520-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
12300 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 080616-1, 4/26/2019; b) 080616-1, 4/26/2019; c) 080616-1, 4/26/2019; d) 080616-1, 4/26/2019.

Recall Number: D-0522-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) SUT1213030SP-11192014, Exp. 11/30/2018; b) SUT1213030SP-11192014, exp. 11/30/2018; c) SUT1213030SP-7222015, Exp.11/30/2018.

Recall Number: D-0484-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
116850 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; b) 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; c) 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018; d) 072516-1, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018

Recall Number: D-0479-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
1300 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 042315-1, Exp. 03/12/2018; b) 042315-1, Exp. 03/12/2018

Recall Number: D-0504-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 072915-1, Exp. 07/05/2019; b) 072915-1, Exp. 07/05/2019

Recall Number: D-0539-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 052615-2, Exp. 4/30/2020; 020916-1, Exp. 12/31/2020; b) 092115-1, Exp. 8/31/2020; 092115-2, Exp. 8/31/2020; 020916-1, Exp. 12/31/2020; 110315-3, Exp. 9/30/2020; c) 020916-1, Exp. 12/31/2020, 110315-2, Exp. 9/30/2020; d) 020916-1, Exp. 12/31/2020

Recall Number: D-0475-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
684 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

Batch or Lot Expiration Information

Lot# : a) 011116-1, Exp. 07/31/2020; b) 011116-1, 011116-2, Exp. 07/31/2020; c) 011116-1, Exp. 07/31/2020

Recall Number: D-0506-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
166000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; b) 020116-2, Exp. 12/13/2020; 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; c) 020116-1, 020116-2, Exp. 12/13/2020; 021115-1, exp. 01/15/2020; 080415-1, Exp. 03/22/2020; 082416-1, 082416-2 Exp. 01/31/2021.

Recall Number: D-0535-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
200000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : b) 030816-1, Exp. 05/20/2018; c) 030816-1, Exp. 05/20/2018; d) 030816-3, Exp. 05/20/2018; e) 030816-2, Exp. 05/20/2018

Recall Number: D-0503-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
5800 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 073115-1, Exp. 6/30/2020; b) 073115-1, Exp. 6/30/2020

Recall Number: D-0532-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
12725 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 013117-1, Exp. 06/30/2019; b) 013117-1, Exp. 06/30/2019; c) 013117-1, Exp. 06/30/2019.

Recall Number: D-0527-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
47500 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 042016-2, Exp. 4/6/2019; b) 041217-1, Exp. 02/09/2019; 042016-2, 042016-3, Exp. 4/6/2019; c) 041217-1, 041217-3, Exp. 02/09/2019; 042016-1, Exp. 04/06/2019; 042016-2, Exp. 4/6/2019; d) 041217-3, Exp. 01/09/2019; 042016-1, Exp. 4/6/2019.

Recall Number: D-0485-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
8300 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 031715-1, Exp. 12/31/2019; b) 031715-1, Exp. 12/31/2019

Recall Number: D-0477-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

Batch or Lot Expiration Information

Lot# : a) 050715-2, Exp. 04/30/2019; b) 050715-2, Exp. 04/30/2019; c) 050715-1, Exp. 04/30/2019.

Recall Number: D-0476-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
55500 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

Batch or Lot Expiration Information

Lot# : a) 021816-2, 021816-3, Exp. 08/24/2018; 70616-1, Exp. 01/31/2019; b) 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019; c) 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019; d) 021816-1, Exp. 08/24/2018; 070616-1, exp. 01/31/2019.

Recall Number: D-0483-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.

Batch or Lot Expiration Information

Lot# : 071015-1, Exp. 3/7/2018

Recall Number: D-0538-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 031815-2, Exp. 1/14/2020; b) 031815-2, Exp. 1/14/2020; c) 031815-2, Exp. 1/14/2020; d) 031815-1, Exp. 1/14/2020

Recall Number: D-0501-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
240 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 092415-1, Exp. 05/21/2018; b) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018; c) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018 d) 092415-1, Exp. 05/21/2018

Recall Number: D-0495-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
26500 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 081015-1, Exp 07/23/2018; b) 081015-1, Exp 07/23/2018; 111116-1, Exp. 10/05/2019; c) 081015-1, Exp. 07/23/2018; 111116-1, Exp. 10/05/2019

Recall Number: D-0531-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
25000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 071316-1, Exp. 05/27/2019; b) 071316-1, Exp. 05/27/2019

Recall Number: D-0528-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
192000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) b) 032117C-1, Exp. 02/11/2020; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019; 071516-3, Exp. 4/1/2019; c) 032117C-1, Exp. 02/11/2020; 070716-1, Exp. 03/22/2019; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019 d) 032117C-1, Exp. 02/11/2020; 061317-1, Exp. 4/30/2020; 061617-1, Exp. 05/01/2020; 070716-1, 070716-2, Exp. 03/22/2019; 121616-1, Exp. 8/20/2019.

Recall Number: D-0490-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
3675 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.

Batch or Lot Expiration Information

Lot# : a) 111516-1, Exp. 9/19/2018; 011817-1, Exp. 9/10/2018; 111616-1, Exp. 5/18/2018; 052317A-1, Exp. 5/27/2019; b) 011817-1, Exp. 9/10/2018; 111616-1, Exp. 5/18/2018; 052317A-1, Exp. 5/27/2019; c) 011817-1, Exp. 9/10/2018; 052317A-1, Exp. 5/27/2019; 111616-1, Exp. 5/18/2018

Recall Number: D-0518-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
1,050,000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 031115-3, Exp. 12/24/2019; b) 031115-3, Exp. 12/24/2019 c) 031115-3, Exp. 12/24/2019; 050815-3, Exp. 04/14/2020; d) 010716-1, 010716-6, Exp. 11/10/2018; 030116-4, Exp. 12/04/2018; 031115-2, Exp. 12/24/2019; 060116-9, Exp. 4/28/2019; 080416-1, 080416-4, Exp. 06/05/2019; 080615-4, Exp. 07/29/2020; 112015-6, Exp. 10/7/2018; 121916-7, Exp. 11/10/2018; e) 080615-5, Exp. 07/29/2020; 010716-4, 010716-5, Exp. 11/10/2018; 030116-2, Exp. 12/04/2018; 031115-5, Exp. 12/24/2019; 060116-1, 060116-4, 060116-5, Exp. 04/28/2019; 080416-1, 080416-2, exp. 06/05/2019; 112015-1, Exp. 10/07/2018; 121916-2,121916-3, 121916-6, Exp. 11/02/2019; f) 112015-5, Exp. 10/07/2018; 010716-1, Exp. 11/10/2018; 030116-3, Exp. 12/04/2018; 010716-1, 010716-2, 010716-3, 010716-8, Exp. 11/10/2018; 030116-1, 030116-3, 030116-4,030116-5, Exp. 12/4/2018; 031115-5, Exp. 12/24/2019; 060116-4, 060116-6, 060116-8, 060116-9, Exp. 04/28/2019; 080416-3, 080416-4, 080416-5, Exp. 06/05/2019; 112015-2, 112015-3, 112015-4,112015-6, 112015-7, Exp. 10/07/2018; 121916-1, Exp. 11/02/2019; 121916-3, 121916-4, 121916-5, 121916-7 121916-8, Exp.11/02/2019; g) 060116-2, 060116-3 060116-7, Exp. 04/28/2019.

Recall Number: D-0488-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
2000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 111516-1, Exp. 09/19/2018; b) 011917A-1, Exp. 09/22/2018; c) 111516-1, Exp. 09/19/2018; d) 011917A-1, Exp. 09/22/2018; 111516-1, Exp. 09/19/2018; e) 011917A-1, Exp. 09/22/2018; 111516-1, Exp. 09/19/2018

Recall Number: D-0487-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 061115-2, Exp. 05/31/2019; b) 061115-1, Exp. 5/31/2019

Recall Number: D-0517-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
20700 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 071117-1, Exp. 06/16/2020; b) 071117-1, Exp. 06/16/2020; c) 071117-1, Exp. 06/16/2020

Recall Number: D-0534-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
50000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 072216-1, Exp. 11/26/2019; b) 072216-1, Exp. 11/26/2019; c)0 72216-1, Exp. 11/26/2019

Recall Number: D-0499-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
4600 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 091115-1, Exp. 07/31/2020; 091115-2, Exp. 07/31/2020; b) 091115-1, Exp. 07/31/2020; c) 091115-1, Exp. 07/31/2020.

Recall Number: D-0537-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10769 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) b) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019; 051515-3, Exp. 02/28/2019; c) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019 d) 012216-1, Exp. 12/31/2019; 051515-2, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; e) 051515-2, exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021; f) 012216-1, Exp. 12/31/2019; 051515-1, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021

Recall Number: D-0478-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
48525 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 080515-2, Exp. 06/05/2019; b) 080515-1, Exp. 06/05/2019; c) 080515-1, Exp. 06/05/2019

Recall Number: D-0519-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
307500 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020.

Recall Number: D-0514-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
24025 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 012616-2, Exp. 01/08/2019; b) 012616-1, Exp. 01/08/2019; 012616-2, Exp. 01/08/2019; c) 012616-1, Exp. 01/08/2019; 012616-3, Exp. 01/08/2019.

Recall Number: D-0492-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
106200 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; 122216-1,122216-2, Exp. 12/31/2020; b) 041017-1, Exp. 11/30/2021; 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; c) 041017-1, 041017-2, Exp. 11/30/2021; 122216-1, 122216-2, exp. 12/31/2020

Recall Number: D-0536-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
7255 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 070815-2, Exp. 04/24/2018; b) 070815-2, Exp. 04/24/2018; c) 070815-2, Exp. 04/24/2018; 110416-2, Exp. 06/30/2019; d) 110416-1, Exp. 06/30/2019; 070815-1, Exp. 04/24/2018.

Recall Number: D-0497-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
52000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 061515-1, Exp. 04/30/2020; b) 080316-1, Exp. 06/30/2021; 052317C-1, Exp 02/28/2022; 061515-1, Exp. 04/30/2020; c) 061515-1, Exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021; d) 061515-1, 061515-2, exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021

Recall Number: D-0521-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
10000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

Batch or Lot Expiration Information

Lot# : 061615-1, Exp.12/31/2019

Recall Number: D-0510-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
12000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8

Batch or Lot Expiration Information

Lot# : 081415-2, Exp. 05/03/2018

Recall Number: D-0508-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
22900 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 110515-2, Exp. 09/30/2018; b) 110515-1, Exp. 09/30/2018; c) 110515-1, Exp. 09/30/2018.

Recall Number: D-0502-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
36100 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 072616-1, Exp. 06/29/2019; b) 060115-1, Exp. 01/23/2018; 072616-1, Exp. 06/29/2019

Recall Number: D-0486-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
75000

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 082815-1, Exp. 06/04/2019; b) 082417-1, Exp. 03/04/2020; 082815-1, Exp. 06/04/2019; c) 082815-1, Exp. 06/04/2019; d) 082815-1, Exp. 06/04/2019

Recall Number: D-0530-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
2100 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 062615-1, Exp. 06/09/2018; 071816-1, exp. 06/05/2019; b) 043015-1, Exp. 04/01/2018; 062615-1, Exp. 06/09/2018; 071816-1, exp. 06/05/2019; c) 062615-1, Exp. 06/09/2018; 071816-1, Exp. 06/05/2019.

Recall Number: D-0505-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
75 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 090517B-2, Exp. 11/17/2019; b) 090517B-2, Exp. 11/17/2019

Recall Number: D-0491-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
5000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# : a) 052915-2, Exp. 05/05/2017; b) 052915-2, Exp. 05/05/2017; c) 052915-1, Exp. 05/05/2017.

Recall Number: D-0507-2018

Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-09-2018
Reported
02-28-2018
Quantity
74000 g

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79149
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Pharmaceutical Ingredients LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2019
Product Description About Product Description
Full technical description of the product.
Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Batch or Lot Expiration Information

Lot# Lots #: a) 110215-2, Exp. 09/30/2020; b) 110215-1, Exp. 09/30/2020; 082516-1, Exp. 05/31/2021; c) 110215-1, Exp. 09/30/2020; 082516-1, Exp. 05/31/2021; d) 110215-1, Exp. 09/30/2020; 082516-1, Exp. 05/31/2021.