Recalls / Class II
Class IID-1246-2020
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
- Affected lot / code info
- Lot # ATP12ZT, Exp. 05/21
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, Grover Beach, California 93433-4221
Distribution
- Quantity
- 9,000 tablets
- Distribution pattern
- Product was distributed in CA and AZ.
Timeline
- Recall initiated
- 2020-04-15
- FDA classified
- 2020-04-16
- Posted by FDA
- 2020-04-22
- Terminated
- 2024-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1246-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.