Drug product
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
D-1246-2020
Product summary
- Event
- Event 85482
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,000 tablets
- Official record key
drug-enforcement:D-1246-2020
Official wording
Reason: cGMP Deviations
Code information: Lot # ATP12ZT, Exp. 05/21
Distribution pattern: Product was distributed in CA and AZ.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations