Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1820-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 1, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 13,229 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1820-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 83479
- Address
- 2550 John Glenn Ave Ste A
- 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
- Postal code
- 43217-1188
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1820-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 13,229 cartons
- Termination date
- Sep 30, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Mar 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2019