Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

FDA recall notice · announced July 3, 2019 · H J Harkins Company Inc Dba Pharma Pac

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

Reason for recall

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Notes

Distribution: Nationwide Within the United States
Lot/code information: Lot #: ACL75M, Exp. 02/20; ACL76M, Exp. 08/19; ACL77M, Exp. 05/20
Quantity: 40 bottles
Status: Terminated
Products in this recall event:
- Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03. (D-1430-2019)
- Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04 (D-1429-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.