The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0164-2019·Announced 2018-11-07

Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

Pharm D Solutions is recalling 442 vials of HCG 6000 unit injectable nationwide due to a lack of 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 are assigned a severity score of 4 (Severe), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in injectable drugs.

Plain-English summary

Pharm D Solutions, LLC is recalling 442 vials of HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable. The product is identified by NDC 69699-1739-06 and was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The affected lots include 04092018:14 (Discard by 10/6/2018), 06042018:54 (Discard by 12/1/2018), and 05292018:81 (Discard by 11/25/2018).

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
442

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 (3)

  • Lot: 04092018:14 Discard by: 10/6/2018
  • 06042018:54 Discard by: 12/1/2018
  • 05292018:81 Discard by: 11/25/2018

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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