Why it was recalled
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Product description
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059
Lot numbers, UPCs & expiration codes
Lot #: 20141218@41, Use by 3/18/2015; 20141226@24, Use by 3/26/2015
Where it was sold
Louisiana
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-0339-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 2, 2015
- FDA report date
- Jan 21, 2015
- Quantity
- 972 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0339-2015, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 70167
- Address
- 8821 Knoedl Ct
- Code information
- Lot #: 20141218@41, Use by 3/18/2015; 20141226@24, Use by 3/26/2015
- Postal code
- 72205-4600
- Report date
- Jan 21, 2015
- Product type
- Drugs
- Recall number
- D-0339-2015
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 972 syringes
- Termination date
- Apr 22, 2015
- Reason for recall
- Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059
- Distribution pattern
- Louisiana
- Recall initiation date
- Jan 2, 2015
- Initial firm notification
- Telephone
- Center classification date
- Jan 14, 2015