Reported Jun 19, 2019 · Terminated

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl.…

Torrent Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle
NDC
- 0536-0122-97
- b) One Pint (473 mL) bottle
NDC0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA

Lot codes and dates: 76 of 76 codes
Lot #s: a) 17E022
17E037
Exp. 05/2019
17G006
17G026
Exp. 07/2019
17H019
17H020
Exp. 08/2019
17J020
Exp. 09/2019
17K006
17K012
Exp. 10/2019
17L028
17L033
Exp. 11/2019
18A001
18A006
18A013
18A038
Exp. 01/2020
18B036
Exp. 02/2020
18C024
Exp. 03/2020
18E009
18E019
18E028
Exp. 05/2020
18F010
Exp. 06/2020
18H003
Exp. 08/2020
18J010
18J012
18J013
18J019
Exp. 09/2020
18K003
18K012
Exp. 10/2020
19A016
Exp. 01/2021. b) 17E036
Exp. 05/2019
17F008
17F008A
Exp. 06/2019
17H030
Exp. 08/2019
17K017
Exp. 10/2019
17L017
Exp. 11/2019
17M031
Exp. 12/2019
18A020
18A040
Exp. 01/2020
18B036
Amount recalled: 1,883,796 bottles

The agency filed one notice per product. You are reading one of them; the other 40 are below.

28 more are in the archive.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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