The Recall Desk
SevereFDA (Drugs)·D-0793-2020·Announced 2020-01-29

Ranitidine Tablets Recalled Due to NDMA Impurity Detection

H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving significant health risks like NDMA impurities.

Plain-English summary

H.J. Harkins Company, Inc. dba Pharma Pac is recalling specific lots of Ranitidine 150 mg tablets. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The affected product consists of Ranitidine 150 mg tablets in 7, 14, 20, 30, and 60-count packages. The specific lot numbers involved are RAN63KG (Exp. 05/20), RAN64KG (Exp. 10/20), RAN65KG (Exp. 11/20), and RAN66KG (Exp. 05/21). The NDC numbers for these products are 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30, and 52959-0502-60.

A total of 7,212 tablets were distributed to physicians in California, Florida, North Carolina, and South Carolina. Patients and healthcare providers should check their inventory for these specific lot numbers and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
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
Manufacturer
H J Harkins Company Inc dba Pharma Pac
Category
Drug — Prescription Medication
Hazard
Affected units
7,212

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #s: RAN63KG Exp. 05/20
  • RAN64KG Exp. 10/20
  • RAN65KG Exp. 11/20
  • RAN66KG Exp. 05/21

Distribution

Distributed in 4 states:

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