Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ranitidine Recalled by H J Harkins Company Inc dba Pharma Pac Due to CGMP Deviations: Presence of NDMA impurity detected in...

Date: January 6, 2020
Company: H J Harkins Company Inc dba Pharma Pac
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact H J Harkins Company Inc dba Pharma Pac directly.

Affected Products

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

Quantity: 7,212 tablets

Why Was This Recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

Where Was This Sold?

This product was distributed to 4 states: CA, FL, NC, SC

Affected (4 states)Not affected

About H J Harkins Company Inc dba Pharma Pac

H J Harkins Company Inc dba Pharma Pac has 9 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report