The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0140-2019·Announced 2018-11-07

Pharm D Solutions Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

Pharm D Solutions is recalling 285 vials of Bacteriostatic Water for Injection because the product lacks assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the lack of sterility assurance in an injectable product represents a significant health risk consistent with the Severe classification for Class II drug recalls.

Plain-English summary

Pharm D Solutions, LLC is recalling 285 vials of Bacteriostatic Water for Injection 10 mL (NDC 69699-1417-10). The recall was initiated because the product lacks assurance of sterility.

The affected lots were distributed nationwide. The specific lots and their discard dates are: Lot 07182018 (12 vials, discard by 1/14/2019), Lot 04042018 (68 vials, discard by 9/30/2018), Lot 05152018 (57 vials, discard by 11/10/2018), and Lot 06202018 (17 vials, discard by 12/17/2018).

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions for further instructions.

The recalled product

Product
Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
285

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)

  • Lots: 07182018:12 Discard by: 1/14/2019
  • 04042018:68 Discard by: 9/30/2018
  • 05152018:57 Discard by: 11/10/2018
  • 06202018:17 Discard by: 12/17/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 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 79 products in this recall →

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