Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures
Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, because they failed impurity specifications.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality failures like impurity specifications in prescription drugs.
Plain-English summary
Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. The product is manufactured by Actavis Elizabeth LLC and distributed by Actavis, Inc. The recall covers specific lots with expiration dates ranging from May 2016 to May 2017.
The recall was initiated because the tablets failed impurities/degradation specifications, specifically being out of specification for impurities. The FDA has classified this as a Class II recall, which indicates a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide in the United States. Patients and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. Consumers should not use the recalled product and should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 257,746
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 3992J141
- Expiry: 5/16
- Lot #: 3993J142
- Lot #: 0695B151
- Expiry: 7/16
- Lot #: 0696B151
- Lot #: 0378A151
- Lot #: 0379A151
- Lot #: 0697B151
- Expiry: 8/16
- Lot #: 2427F151
- Expiry: 11/16
- Lot #: 1947E151
- Lot #: 1330C151
- Lot #: 1331C151
- Lot #: 1946E151
- Lot #: 3652H151
- Expiry: 2/17
- Lot #: 3653H151
- Expiry: 3/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Actavis Elizabeth LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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