The Recall Desk
SevereFDA (Drugs)·D-1322-2019·Announced 2019-06-19

Pharm D Solutions Recalls Bacteriostatic Water for Injection Vials

Pharm D Solutions, LLC is recalling 716 vials of Bacteriostatic Water for Injection due to a lack of sterility assurance.

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 and involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharm D Solutions, LLC is voluntarily recalling 716 vials of Bacteriostatic Water for Injection, 10 mL vials. The recall is being conducted because the product lacks sterility assurance.

The affected product was distributed nationwide within the United States. The specific lots involved are 11292018 (exp. 05/28/2019), 01022019 (exp. 07/01/2019), 02042019 (exp. 08/03/2019), and 03042019 (exp. 08/31/2019).

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC at 1-844-263-6846 for further instructions.

The recalled product

Product
Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Affected units
716

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 #: 11292018:75 Exp. 05/28/2019
  • 01022019:70 Exp. 07/01/2019
  • 02042019:04 Exp. 08/03/2019
  • 03042019:94 Exp. 08/31/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Pharm D Solutions, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →