Multi-event August 2016 FDA Recall Drug by Amerisource Health Services

This Multi-event Class II drug recall was voluntarily initiated by Amerisource Health Services on August 24, 2016 for the product Drug. The FDA reported the reason for recall as unit dose mispackaging; blister cavities may contain more than one tablet /capsule. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1489-2016 TERMINATED D-1484-2016 TERMINATED D-1482-2016 TERMINATED D-1485-2016 TERMINATED D-1483-2016 TERMINATED D-1490-2016 TERMINATED D-1487-2016 TERMINATED D-1486-2016 TERMINATED D-1481-2016 TERMINATED D-1488-2016 TERMINATED

Recall Number: D-1489-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
115 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33

Batch or Lot Expiration Information

Lot# Lot 162490, exp. 9/30/17

Recall Number: D-1484-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
867 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95

Batch or Lot Expiration Information

Lot# Lot 162276, exp. 9/30/17

Recall Number: D-1482-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
2,276 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95

Batch or Lot Expiration Information

Lot# Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17

Recall Number: D-1485-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
156 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95

Batch or Lot Expiration Information

Lot# Lot 162278, exp. 10/31/17

Recall Number: D-1483-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
1,416 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95

Batch or Lot Expiration Information

Lot# Lot 150950, exp. 3/31/17 and lot 154813, exp. 5/31/2017

Recall Number: D-1490-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
761 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33

Batch or Lot Expiration Information

Lot# Lot 152418, exp. 12/31/16, lot 153544, exp. 3/31/17, lot 154835, exp. 5/31/17

Recall Number: D-1487-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
126 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33

Batch or Lot Expiration Information

Lot# Lot 162489, exp. 9/30/17 and lot 162910, exp. 10/31/17

Recall Number: D-1486-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
834 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95

Batch or Lot Expiration Information

Lot# Lot 152254, exp. 12/31/16, lot 152324, exp. 3/31/17, lot 154833, exp. 5/31/17, lot 162406, exp. 12/31/17

Recall Number: D-1481-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
221 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95

Batch or Lot Expiration Information

Lot# Lot 163220, exp. 10/31/17 and lot 164194, exp. 11/20/17

Recall Number: D-1488-2016

Reason for Recall
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Initiated
08-24-2016
Reported
09-14-2016
Quantity
666 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75076
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.
Amerisource Health Services
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in the following states: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95

Batch or Lot Expiration Information

Lot# Lot 152325, exp. 12/31/16, lot 154834, exp. 5/31/17