Why it was recalled
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 04192017@1, Exp 09/30/2017
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0924-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2017
- FDA report date
- Jul 5, 2017
- Quantity
- 25 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apothecary By Design
Original FDA data
Every field from FDA enforcement report D-0924-2017, exactly as published.
Show all FDA fields
- City
- Portland
- State
- ME
- Status
- Terminated
- Country
- United States
- Event ID
- 77615
- Address
- 141 Preble St
- Code information
- Lot #: 04192017@1, Exp 09/30/2017
- Postal code
- 04101-2440
- Report date
- Jul 5, 2017
- Product type
- Drugs
- Recall number
- D-0924-2017
- Classification
- Class II
- Recalling firm
- Apothecary By Design
- Product quantity
- 25 vials
- Termination date
- Oct 6, 2017
- Reason for recall
- Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 5, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jun 28, 2017