Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401.
Lot numbers, UPCs & expiration codes
Lot #s: 17E031, Exp. 05/2019; 18F030, Exp. 06/2020.
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-1364-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 6,000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc
Original FDA data
Every field from FDA enforcement report D-1364-2019, 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: 17E031, Exp. 05/2019; 18F030, Exp. 06/2020.
- Postal code
- 19057-4506
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1364-2019
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc
- Product quantity
- 6,000 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
- Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401.
- 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