Agency classClass IIOur severity:High FDA (Drugs)·D-1616-2015·Announced 2015-09-23

Nandrolone Decanoate Injection Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile injection) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature. The recall involves 169 ml total volume distributed nationwide between November 2014 and May 2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific hazard is a lack of assurance of sterility.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product: Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Steroid
Hazard: sterility
gmp-violation

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 (20)

All lots distributed between November 2014 and May 2015: 02272015@1
8/26/2015
12182015@67
6/16/2015
02062015@141
8/5/2015
04222015@13
9/29/2015
04072015@33
10/4/2015
04212015@13
10/18/2015
04082015@7
10/5/2015
04142015@24
10/11/2015
04272015@84
10/24/2015
and 05082015@7
11/4/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

See all →

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Same hazard · sterility