Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product description
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Lot numbers, UPCs & expiration codes
Lots: a) HK16617A Exp. 11/30/2019, HL03917A Exp. 11/30/2019, HL04017A Exp. 11/30/2019, HM06017A Exp. 11/30/2019, HM06117A Exp. 11/30/2019, HB03518A Exp. 03/31/2020, HB03618A Exp. 03/31/2020, HC14018A Exp. 04/30/2020, HC14118A Exp. 04/30/2020, HC14218A Exp. 04/30/2020, HC14318A Exp. 04/30/2020, HC14418A Exp. 04/30/2020, HC14518A Exp. 05/31/2020, HH04518A Exp. 08/31/2020, HH04618A Exp. 08/31/2020, HH04718A Exp. 08/31/2020, HH04818A Exp. 08/31/2020, HH04918A Exp. 08/31/2020, HK02718A Exp. 10/31/2020, HK06918A Exp. 10/31/2020, HL07418A Exp. 11/30/2020, HL07518A Exp. 11/30/2020, HA00419A Exp. 12/31/2020, HA00519A Exp. 12/31/2020, HA02719A Exp. 12/31/2020, HA02819A Exp. 12/31/2020, HA2719A Exp. 12/31/2020, HC05019A Exp. 03/31/2021, HC05119A Exp. 03/31/2021, HC05911A Exp. 03/31/2021, HE03319A Exp. 04/30/2021, HE03419A Exp. 04/30/2021, HE05419A Exp. 04/30/2021, HG02319A Exp. 06/30/2021, HG02419A Exp. 06/30/2021, HG02619A Exp. 06/30/2021; b) 21570 Exp. 03/31/2020, 21571 Exp. 03/31/2020, 22190 Exp. 03/31/2020, 22192 Exp. 05/31/2020, 22497 Exp. 05/31/2020, 22620 Exp. 05/31/2020, 22999 Exp. 09/30/2020, 23000 Exp. 09/30/2020, 24158 Exp. 03/31/2021, 24159 Exp. 04/30/2021; c) 21241 Exp. 03/31/2020, 21680 Exp. 03/31/2020, 22193 Exp. 03/31/2020, 22657 Exp. 03/31/2020, 23001 Exp. 09/30/2020, 23002 Exp. 09/30/2020, 24157 Exp. 04/30/2021
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-0524-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- 631,138 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0524-2020, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 84287
- Address
- 615 N 1st St
- Code information
- Lots: a) HK16617A Exp. 11/30/2019, HL03917A Exp. 11/30/2019, HL04017A Exp. 11/30/2019, HM06017A Exp. 11/30/2019, HM06117A Exp. 11/30/2019, HB03518A Exp. 03/31/2020, HB03618A Exp. 03/31/2020, HC14018A Exp. 04/30/2020, HC14118A Exp. 04/30/2020, HC14218A Exp. 04/30/2020, HC14318A Exp. 04/30/2020, HC14418A Exp. 04/30/2020, HC14518A Exp. 05/31/2020, HH04518A Exp. 08/31/2020, HH04618A Exp. 08/31/2020, HH04718A Exp. 08/31/2020, HH04818A Exp. 08/31/2020, HH04918A Exp. 08/31/2020, HK02718A Exp. 10/31/2020, HK06918A Exp. 10/31/2020, HL07418A Exp. 11/30/2020, HL07518A Exp. 11/30/2020, HA00419A Exp. 12/31/2020, HA00519A Exp. 12/31/2020, HA02719A Exp. 12/31/2020, HA02819A Exp. 12/31/2020, HA2719A Exp. 12/31/2020, HC05019A Exp. 03/31/2021, HC05119A Exp. 03/31/2021, HC05911A Exp. 03/31/2021, HE03319A Exp. 04/30/2021, HE03419A Exp. 04/30/2021, HE05419A Exp. 04/30/2021, HG02319A Exp. 06/30/2021, HG02419A Exp. 06/30/2021, HG02619A Exp. 06/30/2021; b) 21570 Exp. 03/31/2020, 21571 Exp. 03/31/2020, 22190 Exp. 03/31/2020, 22192 Exp. 05/31/2020, 22497 Exp. 05/31/2020, 22620 Exp. 05/31/2020, 22999 Exp. 09/30/2020, 23000 Exp. 09/30/2020, 24158 Exp. 03/31/2021, 24159 Exp. 04/30/2021; c) 21241 Exp. 03/31/2020, 21680 Exp. 03/31/2020, 22193 Exp. 03/31/2020, 22657 Exp. 03/31/2020, 23001 Exp. 09/30/2020, 23002 Exp. 09/30/2020, 24157 Exp. 04/30/2021
- Postal code
- 38478-2403
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0524-2020
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 631,138 bottles
- Termination date
- Oct 27, 2021
- Reason for recall
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 14, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2019