FDA-Drug2019-07-03Class II

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

H J Harkins Company Inc dba Pharma Pac
Hazard

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

Sold states
Nationwide Within the United States
Affected count
12 bottles
Manufactured in
1400 W Grand Ave Ste F, N/A, Grover Beach, CA, United States
Products
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1430-2019

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