Drug product

Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.

D-1346-2019

May 21, 2019

Class II

Product summary

Firm: Torrent Pharma Inc
Event: Event 82889
Status: Terminated
Classification: Class II
Quantity: 58,272 bottles
Official record key: drug-enforcement:D-1346-2019

Official wording

Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information: Lot #: 17E035, Exp. 05/2019

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

cGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0

contamination with Burkholderia cepacia (B.cepacia) and Ralstonia