CLASS II Drug recall · Reported 29 Jan 2020 · FDA Enforcement Report
Ranitidine, a), b), c), d), e) recalled by H J Harkins Company
H J Harkins is recalling Ranitidine, a), b), c), d), e), distributed in California, Florida, North Carolina, South Carolina. The recall was initiated on 6 Jan 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0793-2020
- FDA event ID
- 84637
- Recalling firm
- H J Harkins, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2020
- FDA classified
- 20 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 6 Jan 2020 | Recall initiated by company | |
| 20 Jan 2020 | Classified by FDA | +14 days |
| 29 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Distributed to Physicians in the following states: CA, FL, NC, and SC.
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21
Where was it sold?
Distributed to Physicians in the following states: CA, FL, NC, and SC.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from H J Harkins
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen and Codeine Phosphate recalled by H J Harkins Company | H J Harkins | Manufacturing (CGMP) Deviations | AZ, CA |
| Drug | CLASS II | Acetaminophen 500 mg tablet packaged in a) 30-count bottles recalled | H J Harkins | Packaging Defects | Nationwide |
| Drug | CLASS II | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g recalled | H J Harkins | Manufacturing (CGMP) Deviations | CA |
| Drug | CLASS II | Diphenhydramine HCL Liquid, 12.5 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |
| Drug | CLASS II | Acetaminophen Children's Liquid, 160 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |