Drug product
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
D-0500-2017
Product summary
- Firm
- Allegiant Health
- Event
- Event 76495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70,176 bottles; 9,000,000 tablets (bulk)
- Official record key
drug-enforcement:D-0500-2017
Official wording
Reason: cGMP deviations - presence of rubber particles found loose in the bulk product.
Code information: Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
rubber particles
-
Manufacturing or process control
cGMP deviations