Drug product
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
D-0040-2015
Product summary
- Event
- Event 69248
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,207,200 tablets
- Official record key
drug-enforcement:D-0040-2015
Official wording
Reason: Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Code information: Lot#12084; Exp. 05/16
Distribution pattern: VA, WA, and CA.
Derived failure modes
-
Potency or specification failure
Subpotent