Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blist...

FDA Drug Recall #D-1820-2019 — Class II — March 1, 2019

Recall Summary

Recall Number D-1820-2019
Classification Class II — Moderate risk
Date Initiated March 1, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm American Health Packaging
Location Columbus, OH
Product Type Drugs
Quantity 13,229 cartons

Product Description

Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33

Reason for Recall

Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.

Distribution Pattern

Nationwide USA

Lot / Code Information

Lot, expiry: Lot 174262, exp. 03/31/2019; Lot 176469, exp. 06/30/2019; Lot 177897, exp. 08/31/2019; Lots 178318 and 178436, exp. 09/30/2019; Lot 179547 and 179656, exp. 11/30/2019

Other Recalls from American Health Packaging

Recall # Classification Product Date
D-0880-2022 Class III Nitrofurantoin Capsules, USP (Monohydrate/Macro... May 3, 2022
D-0790-2022 Class III Cyanocobalamin Injection, USP, 1000 mcg per mL,... Apr 12, 2022
D-0652-2022 Class II Oxycodone Hydrochloride Oral Solution, USP (C-I... Feb 22, 2022
D-0451-2022 Class II Metoprolol Succinate Extended-Release Tablets, ... Dec 20, 2021
D-0020-2022 Class II GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 ... Sep 17, 2021

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

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.