Agency classClass IIOur severity:Severe FDA (Drugs)·D-0744-2021·Announced 2021-08-25

Teva Octreotide Acetate Injection Recall: Sterility Assurance Loss

Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

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: This is an FDA Class II recall. Loss of sterility assurance in an injectable drug represents a significant risk of serious health consequences, including infection, sepsis, and other potentially serious complications. Although no illnesses have been reported in the source text, the hazard itself—compromised sterility in an injectable product—creates substantial risk of harm.

Plain-English summary

Teva Pharmaceuticals USA is recalling Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vials (NDC 0703-3311-01) because the company cannot assure the sterility of the product. The recall affects Lot #31327466B with an expiration date of 08/2021.

The product was distributed nationwide, including Puerto Rico. A total of 3,067 vials are being recalled. Octreotide Acetate is an injectable prescription medication, and sterility is critical for injectable products to prevent infections and other serious complications.

Patients currently using this medication should consult their healthcare provider immediately about their treatment options and whether they need to switch to an alternative supply. Healthcare providers and pharmacies should stop dispensing this lot and contact patients who may have received vials from this lot.

The recalled product

Product: Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable Pharmaceutical
Hazard: sterility-loss
injection-safety
Affected units: 3,067

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 #: 31327466B
exp. date 08/2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Teva Pharmaceuticals USA 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 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility loss