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

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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.