The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1323-2019·Announced 2019-06-19

Pharm D Solutions Recalls B-Complex Injectable Vials Due to Sterility Concerns

Pharm D Solutions, LLC is recalling specific lots of B-complex injectable vials due to a lack of sterility assurance. The affected product is distributed nationwide.

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable product corresponds to a severity score of 4 (Severe).

Plain-English summary

Pharm D Solutions, LLC is recalling B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot # 04032019:23 with an expiration date of 06/11/2019. The NDC number is 69699-1611-30.

The recall covers 4 vials per unit. The product was distributed nationwide within the United States. This is a prescription-only medication.

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

The recalled product

Product
B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
4

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 (1)

  • Lot #: 04032019:23 Exp. 06/11/2019

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 →

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