The Recall Desk
ModerateFDA (Drugs)·D-0924-2017·Announced 2017-07-05

Apothecary by Design Recalls Progesterone Injection Vials Due to Closure Defect

Apothecary by Design is recalling 25 vials of Progesterone Injection in Olive Oil due to a manufacturing defect where metal closures may adhere to rubber stoppers, potentially compromising container integrity.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The defect is a manufacturing control issue affecting container integrity without reported injuries or deaths.

Plain-English summary

Apothecary by Design is recalling 25 vials of Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vials. The affected product is prescription-only and was distributed nationwide in the USA. The specific lot number is 04192017@1, with an expiration date of 09/30/2017.

The recall was initiated due to a lack of processing controls during manufacturing. Specifically, the metal container closure adheres to the rubber stopper on some units of the batch. This defect can impact the integrity of the container closure, which is a critical safety feature for maintaining the sterility and stability of the medication.

Consumers and healthcare providers should stop using the affected vials immediately. The product should be returned to the pharmacy or point of purchase for disposal or credit in accordance with the recalling firm's instructions.

The recalled product

Product
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
Manufacturer
Apothecary By Design
Category
Drug — Injectable Steroid
Hazard
Affected units
25

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 #: 04192017@1
  • Exp 09/30/2017

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · container integrity

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