Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
Lot numbers, UPCs & expiration codes
Lot #s: a) Lot #: 18D027, 18D028, 18D029; Exp. 04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020; 18F016A; 18F017A; 18F037A, Exp. 06/2020; 18J021; 18J023; 18J023A; 18J024, Exp. 09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.
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-1381-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 730,476 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc
Original FDA data
Every field from FDA enforcement report D-1381-2019, 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) Lot #: 18D027, 18D028, 18D029; Exp. 04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020; 18F016A; 18F017A; 18F037A, Exp. 06/2020; 18J021; 18J023; 18J023A; 18J024, Exp. 09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.
- Postal code
- 19057-4506
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1381-2019
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc
- Product quantity
- 730,476 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
- Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
- 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