The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0939-2017·Announced 2017-07-12

Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

Alvogen, Inc. is recalling 5,100 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected 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. 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 agency classification and the nature of the defect (sterility) align with the Severe criteria for Class II recalls.

Plain-English summary

Alvogen, Inc. is recalling 5,100 2 mL single-dose vials of Clindamycin Injection USP (300 mg/2 mL). The product is identified by Lot 73-154-EV and has an expiration date of 12/31/17. The recall was initiated because of a lack of assurance of sterility.

The affected product was distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
Manufacturer
Alvogen, 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: 73-154-EV
  • Exp. 12/31/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Alvogen, 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 3 products in this recall →

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