Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and A...

FDA Drug Recall #D-1487-2016 — Class II — August 24, 2016

Recall Summary

Recall Number D-1487-2016
Classification Class II — Moderate risk
Date Initiated August 24, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Amerisource Health Services
Location Columbus, OH
Product Type Drugs
Quantity 126 cartons

Product Description

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

Reason for Recall

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Distribution Pattern

Product was distributed in the following states: Nationwide

Lot / Code Information

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

Other Recalls from Amerisource Health Services

Recall # Classification Product Date
D-0091-2018 Class II Paroxetine Tablets, USP, 30mg, 100 tablets (10 ... Oct 24, 2017
D-0074-2018 Class III Enalapril Maleate Tablets, USP, 5 mg, 100 Table... Aug 29, 2017
D-0490-2017 Class II CycloSPORINE Capsules, USP, 100 mg, 30 count (5... Feb 8, 2017
D-0520-2017 Class II GlipiZIDE Extended-release tablets, 2.5 mg, 30-... Feb 3, 2017
D-0137-2017 Class III Bupropion Hydrochloride Extended-Release Tablet... Oct 27, 2016

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.