The Recall Desk
SevereFDA (Drugs)·D-0826-2020·Announced 2020-02-12

PD-Rx Recalls Ranitidine Hydrochloride Tablets Due to NDMA Contamination

PD-Rx Pharmaceuticals is recalling specific lots of ranitidine hydrochloride 150 mg tablets because a supplier reported potential NDMA levels above established limits.

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 rating under the rubric, particularly given the presence of a probable carcinogen (NDMA) above established levels.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling specific lots of ranitidine hydrochloride, USP, 150 mg tablets. The recall involves 14-count, 30-count, 60-count, 90-count, and 100-count bottles distributed in Arizona, California, Florida, Illinois, Indiana, Kentucky, Maine, Mississippi, Oklahoma, Oregon, Pennsylvania, and Tennessee.

The recall was initiated after the company received notice from a supplier regarding potential Nitrosodimethylamine (NDMA) amounts above established levels. NDMA is a probable human carcinogen. The affected lots have expiration dates of May 31, 2020, or November 30, 2020.

Consumers and healthcare providers should check their inventory for the specific NDC codes and lot numbers listed in the recall notice. If the product matches the recalled lots, it should be removed from use and returned to the distributor or disposed of according to local regulations.

The recalled product

Product
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard

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 (20)

  • a) H19E83 Exp. 11/30/2020
  • E19A82 Exp. 05/31/2020
  • b) H19B20 Exp. 11/30/2020
  • G19D77 Exp. 05/31/2020
  • C19D84 Exp. 05/31/2020
  • D19A77 Exp. 05/31/2020
  • D19E40 Exp. 05/31/2020
  • c) I19C45 Exp. 11/30/2020
  • E19E42 Exp. 11/30/2020
  • G19B41 Exp. 11/30/2020
  • H19C77 Exp. 11/30/2020
  • E19A34 Exp. 05/31/2020
  • d) H19B61 Exp. 11/30/2020
  • H19C82 Exp. 11/30/2020
  • C19A18 Exp. 05/31/2020
  • C19B13 Exp. 05/31/2020
  • D19B77 Exp. 05/31/2020
  • E19B76 Exp. 05/31/2020
  • e) I19B41 Exp. 11/30/2020
  • D19D51 Exp. 05/31/2020

Distribution

Distributed in 12 states:

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