Recalls / Class II
Class IID-0339-2015
Product
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
- Affected lot / code info
- Lot #: 20141218@41, Use by 3/18/2015; 20141226@24, Use by 3/26/2015
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".
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 972 syringes
- Distribution pattern
- Louisiana
Timeline
- Recall initiated
- 2015-01-02
- FDA classified
- 2015-01-14
- Posted by FDA
- 2015-01-21
- Terminated
- 2015-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.