Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
Lot numbers, UPCs & expiration codes
Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21
Where it was sold
Distributed to Physicians in the following states: CA, FL, NC, and SC.
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-0793-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 6, 2020
- FDA report date
- Jan 29, 2020
- Quantity
- 7,212 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-0793-2020, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84637
- Address
- 1400 W Grand Ave Ste F
- Code information
- Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21
- Postal code
- 93433-4221
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0793-2020
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 7,212 tablets
- Termination date
- Dec 15, 2023
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
- Distribution pattern
- Distributed to Physicians in the following states: CA, FL, NC, and SC.
- Recall initiation date
- Jan 6, 2020
- Initial firm notification
- Center classification date
- Jan 20, 2020