The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1328-2019·Announced 2019-06-19

Pharm D Solutions Recalls Lipo MIC-12 Injectable Vials for Sterility Concerns

Pharm D Solutions, LLC is recalling 669 vials of Lipo MIC-12 injectable solution due to a lack of sterility assurance. The product was 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 and involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Pharm D Solutions, LLC is recalling 669 vials of Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials. The recall was initiated because of a lack of sterility assurance in the product.

The affected product was distributed nationwide within the United States. The recall includes specific lots with expiration dates ranging from August 18, 2019, to November 2, 2019. The source text does not specify the number of units distributed to specific regions or the exact date the recall was announced.

Consumers and healthcare providers should stop using the affected vials and contact Pharm D Solutions, LLC at 1-844-263-6846 for further instructions. The company is located at 1304 South Loop West, Houston, TX 77054.

The recalled product

Product
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
669

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 (7)

  • Lot #: 02202019:53/A Exp. 08/18/2019
  • 04012019:67/A
  • 04022019:47/A Exp. 09/28/2019
  • 04042019:04/A Exp. 09/30/2019
  • 04082019:38/A Exp. 10/02/2019
  • 04302019:49/A Exp. 10/27/2019
  • 05062019:09 Exp. 11/02/2019

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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