ADHD Med Recalled
The US Food and Drug Administration (FDA) announced the recall of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate tablets (mixed salts of a single entity amphetamine product).
What prompted the Class II recall? Amerisource Health Services initiated the recall due to a packaging issue. The blister packs may contain more than one tablet, according to the FDA’s Enforcement Report.
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The impacted lots are listed below.
|
Presentation |
Lot |
Expiration |
Blister NDC |
|
5 mg |
163220 |
October 31, 2017 |
68084-874-95 |
|
5 mg |
164194 |
November 20, 2017 |
68084-874-95 |
|
10 mg |
150130 |
October 31, 2016 |
68084-936-95 |
|
10 mg |
161296 |
August 31, 2017 |
68084-936-95 |
|
15 mg |
150950 |
March 31, 2017 |
60687-133-95 |
|
15 mg |
154813 |
May 31, 2017 |
60687-133-95 |
|
20 mg |
162276 |
September 30, 2017 |
68084-943-95 |
|
30 mg |
162278 |
October 31, 2017 |
60687-154-95 |
|
10 mg |
152254 |
December 31, 2016 |
68084-815-95 |
|
10 mg |
152324 |
March 31, 2017 |
68084-815-95 |
|
10 mg |
154833 |
May 31, 2017 |
68084-815-95 |
|
10 mg |
162406 |
December 31, 2017 |
68084-815-95 |
|
15 mg |
162489 |
September 30, 2017 |
68084-898-33 |
|
15 mg |
162910 |
October 31, 2017 |
68084-898-33 |
|
20 mg |
152325 |
December 31, 2016 |
68084-832-95 |
|
20 mg |
154834 |
May 31, 2017 |
68084-832-95 |
|
25 mg |
162490 |
September 30, 2017 |
68084-909-33 |
|
30 mg |
152418 |
December 31, 2016 |
68084-887-33 |
|
30 mg |
153544 |
March 31, 2017 |
68084-887-33 |
|
30 mg |
154835 |
May 31, 2017 |
68084-887-33 |
--Stephanie Vaccaro
Reference:
US Food and Drug Administration. FDA Enforcement Report – Week of September 14, 2016. www.fda.gov. Accessed September 15, 2016.


