Why it was recalled
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Product description
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Lot numbers, UPCs & expiration codes
Lot: 11/01/18 8847 80261S, BUD: 03/31/19
Where it was sold
Heath care facilities in NM, TX, and OH
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-0347-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 29, 2018
- FDA report date
- Jan 2, 2019
- Quantity
- 225 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0347-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81685
- Address
- 9265 Kirby Dr
- Code information
- Lot: 11/01/18 8847 80261S, BUD: 03/31/19
- Postal code
- 77054-2520
- Report date
- Jan 2, 2019
- Product type
- Drugs
- Recall number
- D-0347-2019
- Classification
- Class I
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 225 syringes
- Termination date
- May 2, 2019
- Reason for recall
- Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
- Distribution pattern
- Heath care facilities in NM, TX, and OH
- Recall initiation date
- Nov 29, 2018
- Initial firm notification
- Telephone
- Center classification date
- Jan 7, 2019