Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village...
FDA Drug Recall #D-1181-2022 — Class II — June 10, 2022
Recall Summary
| Recall Number | D-1181-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 10, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Wedgewood Village Pharmacy, LLC |
| Location | Swedesboro, NJ |
| Product Type | Drugs |
| Quantity | 1 suspension bottle |
Product Description
Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085
Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distribution Pattern
Products were distributed nationwide in the USA.
Lot / Code Information
Lot #: 000-03715131, Exp Date: 07/19/22
Other Recalls from Wedgewood Village Pharmacy, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1186-2022 | Class II | Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty:... | Jun 10, 2022 |
| D-1182-2022 | Class II | Doxycycline (as Calcium) (equivalent to 50mg/5m... | Jun 10, 2022 |
| D-1183-2022 | Class II | Boric Acid 600 mg capsules, 14 capsules per box... | Jun 10, 2022 |
| D-1184-2022 | Class II | Boric Acid 600 mg per suppository, 14 Vaginal S... | Jun 10, 2022 |
| D-1185-2022 | Class II | Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty:... | Jun 10, 2022 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.