Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product description
Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
Lot numbers, UPCs & expiration codes
64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23
Where it was sold
Nationwide
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-0974-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2022
- FDA report date
- Jun 8, 2022
- Quantity
- 96966 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0974-2022, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90229
- Address
- 2 Tower Center Blvd Ste 1102
- Code information
- 64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23
- Postal code
- 08816-1100
- Report date
- Jun 8, 2022
- Product type
- Drugs
- Recall number
- D-0974-2022
- Classification
- Class II
- Recalling firm
- Strides Pharma Inc.
- Product quantity
- 96966 bottles
- Termination date
- Oct 20, 2023
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
- Distribution pattern
- Nationwide
- Recall initiation date
- May 18, 2022
- Center classification date
- May 28, 2022