Recalls / Class II

Class IID-1366-2019

Product

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, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.

Affected lot / code info

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, Exp. 02/2020; 18C032, Exp. 03/2020; 18E004; 18E032, Exp. 05/2020; 18F001, Exp. 06/2020; 18H006, Exp. 08/2020; 18K032, Exp. 10/2020; 18L003, Exp. 11/2020; 19A007, Exp. 01/2021.

Why it was recalled

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

Recalling firm

Firm

Torrent Pharma Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506

Distribution

Quantity

1,883,796 bottles

Distribution pattern

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

Timeline

Recall initiated

2019-05-21

FDA classified

2019-06-13

Posted by FDA

2019-06-19

Terminated

2020-10-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1366-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.