FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Torrent Pharma Pain & Fever Oral Solution Recall

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol f…

Torrent Pharma Inc · Levittown, PA

Risk level
Class II
Reported by FDA
Jun 19, 2019
Recall ID
D-1366-2019
Check your lot numberHow we source this data

Summary

Torrent Pharma recalled Pain & Fever Oral Solution starting May 21, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1366-2019 on Jun 19, 2019. Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Status: Terminated.

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration 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, 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.

Where it was sold

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

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1366-2019
Classification
Class II
Status
Terminated
Recall initiated
May 21, 2019
FDA report date
Jun 19, 2019
Quantity
1,883,796 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Torrent Pharma Inc

Original FDA data

Every field from FDA enforcement report D-1366-2019, exactly as published.

Show all FDA fields
City
Levittown
State
PA
Status
Terminated
Country
United States
Event ID
82889
Address
2091 Hartel Ave
Code information
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.
Postal code
19057-4506
Report date
Jun 19, 2019
Product type
Drugs
Recall number
D-1366-2019
Classification
Class II
Recalling firm
Torrent Pharma Inc
Product quantity
1,883,796 bottles
Termination date
Oct 6, 2020
Reason for recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Recall initiation date
May 21, 2019
Initial firm notification
Letter
Center classification date
Jun 13, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1366-2019, published Jun 19, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls