Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
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
Affected NDCs
52959-0502-07
52959-0502-14
52959-0502-20
52959-0502-30
52959-0502-60
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Drug: Ranitidine Category: Heartburn & Stomach Medication
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0793-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ranitidine recalls
See all
Class II · Moderate risk
Ranitidine 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
ranitidine hydrochloride
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Other recalls by H J Harkins Company Inc dba Pharma Pac
All 2020 recalls
Class II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class II · Moderate risk
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class II · Moderate risk
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone…
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Diphenhydramine HCL Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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