Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pha...
FDA Drug Recall #D-0339-2015 — Class II — January 2, 2015
Recall Summary
| Recall Number | D-0339-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 2, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SCA Pharmaceuticals |
| Location | Little Rock, AR |
| Product Type | Drugs |
| Quantity | 972 syringes |
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
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".
Distribution Pattern
Louisiana
Lot / Code Information
Lot #: 20141218@41, Use by 3/18/2015; 20141226@24, Use by 3/26/2015
Other Recalls from SCA Pharmaceuticals
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0945-2023 | Class II | FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% ... | Jul 20, 2023 |
| D-0555-2023 | Class III | Oxytocin 30 units added to 0.9% Sodium Chloride... | Apr 10, 2023 |
| D-0363-2023 | Class III | Fentanyl 1,500 mcg/30 mL syringe, Injection for... | Feb 24, 2023 |
| D-0829-2022 | Class II | Norepinephrine 8mg in 0.9% Sodium Chloride 250 ... | Apr 25, 2022 |
| D-0831-2022 | Class II | Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 5... | Apr 25, 2022 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.