Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Lot numbers, UPCs & expiration codes
Lot #s: a) 17F003, Exp. 06/2019; 17J011, Exp. 09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A035; Exp. 01/2020; 18B022; 18B027, Exp. 02/2020; 18C036, Exp. 03/2020; 18D009; 18D024, Exp. 04/2020. b) 17G018, Exp. 07/2019; 17H001; 17H010; 17H014, Exp. 08/2019; 17J009, Exp. 09/2019; 17K023, Exp. 10/2019; 17L006; 17L025, Exp. 11/2019; 17M025; 17M034; Exp. 12/2019; 18A005; 18A012; 18A016, Exp. 01/2020; 18B020, Exp. 02/2020; 18C023; 18C031, Exp. 03/2020; 18E017, Exp. 05/2020; 18G005; 18G022, Exp. 07/2020; 18H021; 18H026, Exp. 08/2020; 18J003Exp. 09/2020.
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-1349-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 984,888 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc
Original FDA data
Every field from FDA enforcement report D-1349-2019, 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) 17F003, Exp. 06/2019; 17J011, Exp. 09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A035; Exp. 01/2020; 18B022; 18B027, Exp. 02/2020; 18C036, Exp. 03/2020; 18D009; 18D024, Exp. 04/2020. b) 17G018, Exp. 07/2019; 17H001; 17H010; 17H014, Exp. 08/2019; 17J009, Exp. 09/2019; 17K023, Exp. 10/2019; 17L006; 17L025, Exp. 11/2019; 17M025; 17M034; Exp. 12/2019; 18A005; 18A012; 18A016, Exp. 01/2020; 18B020, Exp. 02/2020; 18C023; 18C031, Exp. 03/2020; 18E017, Exp. 05/2020; 18G005; 18G022, Exp. 07/2020; 18H021; 18H026, Exp. 08/2020; 18J003Exp. 09/2020.
- Postal code
- 19057-4506
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1349-2019
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc
- Product quantity
- 984,888 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
- Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
- 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