The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1199-2016·Announced 2016-07-20

Medaus Recalls L-Phenylalanine Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of L-Phenylalanine 15mg/mL vials because the FDA cannot assure the product is sterile.

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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated Severe (4). While specific injury reports are not detailed in the text, the 'Lack of Assurance of Sterility' for an injectable product represents a significant risk of serious adverse health consequences, aligning with the Severe criteria for Class II drug recalls.

Plain-English summary

Medaus, Inc. is voluntarily recalling 50 mL vials of L-Phenylalanine 15mg/mL (PF) under FDA recall number D-1199-2016. The recall is being conducted because the agency cannot assure the sterility of the product. The affected product is identified by Lot # 160308-2 with a beyond-use date of 09/04/16.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a refund. Patients should consult their healthcare providers for alternative treatment options if necessary.

The recalled product

Product
L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable
Hazard

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 (2)

  • Lot #: 160308-2
  • BUD: 09/04/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 88 recalled by Medaus, Inc. 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 88 products in this recall →

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